A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Phase 3

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: IV Tulisokibart; Drug: SC Tulisokibart; Drug: IV Placebo; Drug: SC Placebo

• Registration Number: NCT06052059
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission according to the Modified Mayo Score at Week 12.

Detailed Description

The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Study Start: 2023-10-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-11-21
• Study Completion: 2029-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

• Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before randomization

• Has moderately to severely active UC

• Weight ≥40 kg

• Satisfies at least 1 of the following criteria:

  • Has had an inadequate response or loss of response to 1 or more protocol-specified UC treatments
  • Protocol specified corticosteroid dependence
  • Has been intolerant to 1 or more protocol-specified UC treatments

• Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

• Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority

• A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding and Is not a participant of childbearing potential (POCBP); or is a POCBP and uses an acceptable contraceptive method, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention, medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy

Exclusion Criteria

• Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment.
• Has a current diagnosis of fulminant colitis and/or toxic megacolon
• Has UC limited to the rectum (i.e, must have evidence of UC extending beyond the rectosigmoid junction, which is ~10 cm from the anal margin)
• Has a current or impending need for colostomy or ileostomy
• Has had a total proctocolectomy or partial colectomy
• Has received fecal microbial transplantation within 4 weeks before randomization
• Has had UC exacerbation requiring hospitalization within 2 weeks before screening
• Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
• Has any active or serious infections without resolution after adequate treatment
• Has had cytomegalovirus infection that resolved less than 4 weeks before screening
• Has a transplanted organ which requires continued immunosuppression
• Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
• Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidelines), or inadequately treated TB (for participants with history of TB)
• Has confirmed or suspected COVID-19
• Has a history of drug or alcohol abuse within 6 months prior to screening
• Has had major surgery within 3 months before screening or has a major surgery planned during the study
• Is currently receiving or is planning to receive total parenteral nutrition at any time during study treatment
• Has received UC-related antibiotics and has not been on stable doses for at least 14 days before randomization or has discontinued these medications within 14 days of randomization
• Requires treatment with a therapy that does not adhere to the protocol-specified guidance parameters
• Has received protocol-specified prohibited medications
• Has had prior exposure to tulisokibart or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study 1: Placebo	IV Tulisokibart	Participants receive IV placebo, followed by an SC placebo regimen.
Study 1: Low Dose Extension	SC Tulisokibart	Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 2: High Dose Induction	IV Tulisokibart	Participants receive high dose IV tulisokibart.
Study 1: High Dose Induction, High Dose Maintenance	IV Tulisokibart	Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Study 1: High Dose Induction, Low Dose Maintenance	SC Tulisokibart	Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 2: Placebo	IV Tulisokibart	Participants receive IV placebo.
Study 1: Low Dose Induction, Low Dose Maintenance	SC Placebo	Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: Placebo	IV Placebo	Participants receive IV placebo, followed by an SC placebo regimen.
Study 1: Placebo	SC Placebo	Participants receive IV placebo, followed by an SC placebo regimen.
Study 2: Placebo	IV Placebo	Participants receive IV placebo.
Study 1: Low Dose Induction, Low Dose Maintenance	SC Tulisokibart	Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 2: High Dose Extension	SC Tulisokibart	Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 1: High Dose Induction, High Dose Maintenance	SC Tulisokibart	Participants receive high dose intravenous (IV) tulisokibart, followed by a high dose subcutaneous (SC) tulisokibart regimen.
Study 1: High Dose Induction, Low Dose Maintenance	SC Placebo	Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: Low Dose Induction, Low Dose Maintenance	IV Tulisokibart	Participants receive low dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 1: High Dose Extension	SC Tulisokibart	Participants receive a high dose SC tulisokibart regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 1: Low Dose Extension	SC Placebo	Participants receive a low dose SC tulisokibart and placebo regimen. Participants may be enrolled in this arm after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 2: Low Dose Induction	IV Tulisokibart	Participants receive low dose IV tulisokibart.
Study 2: Placebo	SC Placebo	Participants receive IV placebo.
Study 2: Low Dose Extension	SC Placebo	Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.
Study 1: High Dose Induction, Low Dose Maintenance	IV Tulisokibart	Participants receive high dose IV tulisokibart, followed by a low dose SC tulisokibart regimen.
Study 2: Low Dose Extension	SC Tulisokibart	Participants receive a low dose SC tulisokibart regimen. Participants may be enrolled in this arm only after completing participation in their original arm, if they meet protocol-specific prerequisites.

Primary Outcome Measures

Name	Time	Method
Study 1: Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12	Week 12	The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 1: Percentage of Participants Achieving Clinical Remission Per MMS at Week 52	Week 52	The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 2: Percentage of Participants Achieving Clinical Remission Per MMS at Week 12	Week 12	The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.

Secondary Outcome Measures

Name	Time	Method
Study 1: Percentage of Participants With Endoscopic Remission at Week 12	Week 12	ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 12	Week 12	Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 12	Week 12	Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Study 1: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12	Week 12	The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Study 1: Change from Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 12	Baseline and Week 12	The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Study 1: Percentage of Participants With One or More Adverse Events (AEs)	Up to approximately 52 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE will be reported.
Study 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE	Up to approximately 52 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Study 1: Percentage of Participants Achieving Clinical Response Per Partial Modified Mayo Score (pMMS) at Week 2	Week 2	The partial Modified Mayo Score (pMMS) is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Study 1: Percentage of Participants With Endoscopic Improvement at Week 12	Week 12	Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12	Week 12	The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12	Week 12	HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12	Week 12	pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Percentage of Diagnostic Assay Positive (Dx+) Participants Achieving Clinical Remission Per MMS at Week 12	Week 12	Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Percentage of Dx+ Participants With Endoscopic Improvement at Week 12	Week 12	Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving Histologic-Endoscopic Remission (HER) at Week 12	Week 12	HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants with Endoscopic Improvement at Week 52	Week 52	Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving Corticosteroid-Free Clinical Remission Per MMS at Week 52	Week 52	The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Corticosteroid-free clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, and no corticosteroid use for ≥90 days before Week 52.
Study 1: Percentage of Participants Achieving HEMI at Week 52	Week 52	HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 52	Week 52	pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Study 1: Percentage of Participants Achieving Sustained Clinical Remission Per MMS at Both Week 12 and Week 52	Week 12 and Week 52	The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Sustained clinical remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS, at both Week 12 and Week 52.
Study 1: Percentage of Participants Reporting No Bowel Urgency at Week 52	Week 52	Bowel urgency is measured using an NRS, which rates bowel urgency on a 0-11 scale of increasing severity. Resolution is defined as a score of 0 or 1 in participants who had a baseline score of 3 or more.
Study 1: Percentage of Participants Reporting No Abdominal Pain at Week 52	Week 52	Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Study 1: Percentage of Participants With Endoscopic Remission at Week 52	Week 52	ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Study 1: Percentage of Participants with Sustained Endoscopic Improvement at Both Week 12 and Week 52	Week 12 and Week 52	Sustained endoscopic improvement is defined as an ES of 0 or 1 at both Week 12 and Week 52. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 1: Percentage of Participants Achieving HER at Week 52	Week 52	HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 1: Percentage of Participants Achieving IBDQ Remission at Week 52	Week 52	The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Study 1: Change from Baseline in FACIT-Fatigue Score at Week 52	Baseline and Week 52	The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Study 1: Percentage of Dx+ Participants Achieving Clinical Remission Per MMS at Week 52	Week 52	Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Study 1: Percentage of Dx+ Participants With Endoscopic Improvement at Week 52	Week 52	Dx+ participants are those who meet protocol-specific diagnostic assay criteria during screening. Endoscopic improvement is defined as ES of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 2: Percentage of Participants With One or More AEs	Up to approximately 12 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
Study 2: Percentage of Participants Who Discontinued Study Intervention Due to an AE	Up to approximately 12 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Study 2: Percentage of Participants with Clinical Response Per pMMS at Week 2	Week 2	pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as pMMS reduction of 1 or more points and 30% or more, plus a reduction of 1 or more points in RBS or an absolute RBS of 0 or 1.
Study 2: Percentage of Participants With Endoscopic Improvement at Week 12	Week 12	Endoscopic improvement is defined as Mayo endoscopic subscore (ES) of 0 or 1. The ES measures UC severity based on endoscopy on a 0-3 scale of increasing severity.
Study 2: Percentage of Participants Achieving a Clinical Response Per MMS at Week 12	Week 12	The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: ES, scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); SFS, scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and RBS, scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical response is defined as an MMS reduction of 2 or more points and 30% or more, plus a reduction of more than 1 point in RBS or an absolute RBS of 0 or 1.
Study 2: Percentage of Participants Achieving HEMI at Week 12	Week 12	HEMI is defined as a Geboes score of 3.1 or less and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation. ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration).
Study 2: Percentage of Participants Achieving Clinical Remission Per pMMS at Week 12	Week 12	pMMS is a composite score of UC disease activity on a scale of increasing severity from 0-6, calculated by summing two subscores: SFS, scored from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). Clinical remission per pMMS is defined as an RBS of 0 and SFS of ≤1.
Study 2: Percentage of Participants With Endoscopic Remission at Week 12	Week 12	ES measures UC severity based on endoscopy, scored from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration). Endoscopic remission is defined as an ES of 0.
Study 2: Percentage of Participants Reporting No Bowel Urgency at Week 12	Week 12	Bowel urgency is measured using a numeric rating scale (NRS), which rates bowel urgency on a 0-11 scale of increasing severity.
Study 2: Percentage of Participants Reporting No Abdominal Pain at Week 12	Week 12	Abdominal pain is measured on a 0-4 NRS of increasing pain severity. Absence of abdominal pain is defined as a rating of 0.
Study 2: Percentage of Participants Achieving IBDQ Remission at Week 12	Week 12	The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224. IBDQ remission is defined as a score of at least 170.
Study 2: Change from Baseline in FACIT-Fatigue Score at Week 12	Baseline and Week 12	The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function, scored on a 0-52 point scale, with greater scores indicating a better fatigue-related quality of life. The change from baseline in FACIT-Fatigue score will be presented.
Study 2: Percentage of Participants Achieving HER at Week 12	Week 12	HER is defined as a Geboes score of less than 2 and ES of 0 or 1. The Geboes score is a histologic grading system for inflammation in UC with scores ranging from 0 to 5.4, with higher scores indicating more severe inflammation.

Trial Locations

Locations (422)

Digestive Health Specialists ( Site 0135); 🇺🇸 Dothan, Alabama, United States

IMC-Gulf Coast Gastroenterology ( Site 0157); 🇺🇸 Fairhope, Alabama, United States

Research Solutions of Arizona ( Site 3816); 🇺🇸 Litchfield Park, Arizona, United States

Southern California Research Center ( Site 3828); 🇺🇸 Coronado, California, United States

Cedars-Sinai Medical Center ( Site 0119); 🇺🇸 Los Angeles, California, United States

GI Alliance - Sun City ( Site 0103); 🇺🇸 Sun City, Arizona, United States

University of Florida College of Medicine-Gastroenterology ( Site 3821); 🇺🇸 Gainesville, Florida, United States

Clinnova Research ( Site 3803); 🇺🇸 Anaheim, California, United States

UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113); 🇺🇸 La Jolla, California, United States

University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 0172); 🇺🇸 Aurora, Colorado, United States

Peak Gastroenterology Associates ( Site 0116); 🇺🇸 Colorado Springs, Colorado, United States

Rocky Mountain Gastroenterology/Topography Health ( Site 3838); 🇺🇸 Littleton, Colorado, United States

Connecticut Clinical Research Institute ( Site 0126); 🇺🇸 Bristol, Connecticut, United States

Medical Research Center of Connecticut ( Site 0151); 🇺🇸 Hamden, Connecticut, United States

Yale University School of Medicine-Digestive Disease ( Site 0163); 🇺🇸 New Haven, Connecticut, United States

Emerson Clinical Research Institute ( Site 3820); 🇺🇸 Washington, District of Columbia, United States

Gastroenterology Consultants of Clearwater ( Site 0152); 🇺🇸 Clearwater, Florida, United States

Nature Coast Clinical Research - Inverness ( Site 3806); 🇺🇸 Inverness, Florida, United States

Central Florida Gastro Research ( Site 0124); 🇺🇸 Kissimmee, Florida, United States

Emory University School of Medicine ( Site 3818); 🇺🇸 Atlanta, Georgia, United States

Orlando Health ( Site 0145); 🇺🇸 Orlando, Florida, United States

Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115); 🇺🇸 Atlanta, Georgia, United States

Atlanta Center for Gastroenterology ( Site 0155); 🇺🇸 Decatur, Georgia, United States

University of Chicago Medical Center ( Site 0134); 🇺🇸 Chicago, Illinois, United States

GI Alliance - Glenview ( Site 0168); 🇺🇸 Glenview, Illinois, United States

GI ALLIANCE - GURNEE ( Site 0107); 🇺🇸 Gurnee, Illinois, United States

Iowa Digestive Disease Center ( Site 0123); 🇺🇸 Clive, Iowa, United States

University of Louisville Hospital-Clinical Trials Unit ( Site 0165); 🇺🇸 Louisville, Kentucky, United States

Baton Rouge General Medical Center - Bluebonnet ( Site 0112); 🇺🇸 Baton Rouge, Louisiana, United States

Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154); 🇺🇸 New Orleans, Louisiana, United States

Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 3835); 🇺🇸 Glen Burnie, Maryland, United States

Massachusetts General Hospital-Crohn's and Colitis Center ( Site 0132); 🇺🇸 Boston, Massachusetts, United States

University of Michigan ( Site 0143); 🇺🇸 Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan, LLC ( Site 0108); 🇺🇸 Clinton Township, Michigan, United States

Clinical Research Institute of Michigan, LLC ( Site 0150); 🇺🇸 Troy, Michigan, United States

Huron Gastroenterology ( Site 3836); 🇺🇸 Ypsilanti, Michigan, United States

Mayo Clinic in Rochester, Minnesota ( Site 0147); 🇺🇸 Rochester, Minnesota, United States

BVL Research - Kansas ( Site 3847); 🇺🇸 Liberty, Missouri, United States

Washington University School of Medicine ( Site 0129); 🇺🇸 Saint Louis, Missouri, United States

Circuit Clinical /Middletown Medical PC ( Site 3831); 🇺🇸 Middletown, New York, United States

NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 3846); 🇺🇸 New York, New York, United States

Lenox Hill Hospital ( Site 0128); 🇺🇸 New York, New York, United States

New York Gastroenterology Associates ( Site 0159); 🇺🇸 New York, New York, United States

University of North Carolina Medical Center ( Site 0140); 🇺🇸 Chapel Hill, North Carolina, United States

Carolina Digestive Diseases and Endoscopy Center ( Site 3809); 🇺🇸 Greenville, North Carolina, United States

Hospital of the University of Pennsylvania ( Site 0170); 🇺🇸 Philadelphia, Pennsylvania, United States

University Gastroenterology ( Site 0164); 🇺🇸 Providence, Rhode Island, United States

Gastroenterology Associates of Orangeburg ( Site 0149); 🇺🇸 Orangeburg, South Carolina, United States

Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131); 🇺🇸 Nashville, Tennessee, United States

Quality Medical Research ( Site 3807); 🇺🇸 Nashville, Tennessee, United States

GI Alliance - Garland ( Site 0109); 🇺🇸 Garland, Texas, United States

Baylor College of Medicine Medical Center ( Site 3812); 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero ( Site 0144); 🇺🇸 Houston, Texas, United States

Clinical Trial Network ( Site 3819); 🇺🇸 Houston, Texas, United States

GI Alliance - Lubbock ( Site 0167); 🇺🇸 Lubbock, Texas, United States

Caprock Gastro Research ( Site 0101); 🇺🇸 Lubbock, Texas, United States

GI Alliance: Mansfield ( Site 0161); 🇺🇸 Mansfield, Texas, United States

CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122); 🇺🇸 San Antonio, Texas, United States

Southern Star Research Institute ( Site 0106); 🇺🇸 San Antonio, Texas, United States

GI Alliance - San Marcos ( Site 0130); 🇺🇸 San Marcos, Texas, United States

GI Alliance - Southlake ( Site 0104); 🇺🇸 Southlake, Texas, United States

Tyler Research Institute ( Site 0105); 🇺🇸 Tyler, Texas, United States

Texas Digestive Disease Consultants ( Site 0136); 🇺🇸 Webster, Texas, United States

Velocity Clinical Research, Salt Lake City ( Site 3801); 🇺🇸 West Jordan, Utah, United States

Richmond VA Medical Center ( Site 3845); 🇺🇸 Richmond, Virginia, United States

Washington Gastroenterology - Bellevue ( Site 3844); 🇺🇸 Bellevue, Washington, United States

Washington Gastroenterology - Tacoma ( Site 0102); 🇺🇸 Tacoma, Washington, United States

MEDICAL COLLEGE OF WISCONSIN ( Site 0141); 🇺🇸 Milwaukee, Wisconsin, United States

Centro de Investigaciones Médicas Mar del Plata ( Site 2101); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

CER medical Institute-Gastroenterology ( Site 2110); 🇦🇷 Quilmes, Caba, Argentina

Hospital Provincial del Centenario ( Site 2108); 🇦🇷 Rosario, Santa Fe, Argentina

C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103); 🇦🇷 San Miguel de Tucumán, Tucuman, Argentina

Nepean Hospital-Gastroenterology/Hepatology ( Site 2501); 🇦🇺 Kingswood, New South Wales, Australia

Concord Repatriation General Hospital-Gastroenterology and Liver Services ( Site 2508); 🇦🇺 Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital ( Site 2500); 🇦🇺 Brisbane, Queensland, Australia

Mater Misericordiae Limited-Gastroenterology ( Site 2506); 🇦🇺 Brisbane, Queensland, Australia

Royal Adelaide Hospital-Gastroenterology/Hepatology ( Site 2504); 🇦🇺 Adelaide, South Australia, Australia

Monash Health-Gastroenterology ( Site 2505); 🇦🇺 Clayton, Victoria, Australia

The Alfred Hospital-Gastroenterology ( Site 2503); 🇦🇺 Melbourne, Victoria, Australia

St Vincent's Hospital ( Site 2510); 🇦🇺 Melbourne, Victoria, Australia

Universitaetsklinik fuer Innere Medizin I Innsbruck ( Site 0200); 🇦🇹 Innsbruck, Tirol, Austria

Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H ( Site 0202); 🇦🇹 Vienna, Wien, Austria

Uniklinikum Salzburg-Innere Medizin I ( Site 0201); 🇦🇹 Salzburg, Austria

UZ Gent ( Site 0300); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

UZ Leuven-Gastroenterology - Inflammatory Bowel Disease ( Site 0301); 🇧🇪 Leuven, Vlaams-Brabant, Belgium

MC Velingrad 2017 EOOD ( Site 0406); 🇧🇬 Velingrad, Pazardzhik, Bulgaria

DKC V - Plovdiv ( Site 0402); 🇧🇬 Plovdiv, Bulgaria

"Diagnostic - Consultative Center XX - Sofia" EOOD ( Site 0407); 🇧🇬 Sofia, Sofia (stolitsa), Bulgaria

MC Rusemed ( Site 0408); 🇧🇬 Ruse, Bulgaria

MHAT Hadzhi Dimitar-Gastroenterology ( Site 0403); 🇧🇬 Sliven, Bulgaria

Medica Plus Medical Center ( Site 0404); 🇧🇬 Veliko Tarnovo, Bulgaria

Heritage Medical Research Clinic ( Site 0004); 🇨🇦 Calgary, Alberta, Canada

Diagnostic Consultative Center 22 - Sofia ( Site 0401); 🇧🇬 Sofia, Bulgaria

4th MHAT ( Site 0409); 🇧🇬 Sofia, Bulgaria

G.I.R.I. GI Research Institute Foundation ( Site 0001); 🇨🇦 Vancouver, British Columbia, Canada

Barrie GI Associates ( Site 0012); 🇨🇦 Barrie, Ontario, Canada

University Hospital - London Health Sciences Centre ( Site 0002); 🇨🇦 London, Ontario, Canada

Victoria Hospital & Children's Hospital - London Health Sciences Centre ( Site 0007); 🇨🇦 London, Ontario, Canada

West GTA Research Inc. ( Site 0017); 🇨🇦 Mississauga, Ontario, Canada

Toronto Immune & Digestive Health Institute ( Site 0005); 🇨🇦 Toronto, Ontario, Canada

Toronto Digestive Disease Associates ( Site 0006); 🇨🇦 Vaughan, Ontario, Canada

Montreal General Hospital ( Site 0003); 🇨🇦 Montreal, Quebec, Canada

ABP Research Services Corp. ( Site 0016); 🇨🇦 Ontario, Canada

Diex Recherche Quebec ( Site 0008); 🇨🇦 Quebec, Canada

Clinical Research Chile SpA ( Site 2201); 🇨🇱 Valdivia, Los Rios, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 2203); 🇨🇱 Santiago, Region M. De Santiago, Chile

FALP-UIDO ( Site 2208); 🇨🇱 Santiago, Region M. De Santiago, Chile

Clínica Universidad de Los Andes ( Site 2202); 🇨🇱 Santiago, Region M. De Santiago, Chile

Clínica Alemana de Santiago ( Site 2209); 🇨🇱 Santiago, Region M. De Santiago, Chile

Clínica MEDS La Dehesa ( Site 2207); 🇨🇱 Santiago, Region M. De Santiago, Chile

CECIM ( Site 2200); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-CICUC ( Site 2205); 🇨🇱 Santiago, Region M. De Santiago, Chile

The First Affiliated Hospital of Anhui Medical University ( Site 3957); 🇨🇳 Hefei, Anhui, China

Beijing Friendship Hospital Affiliate of Capital University ( Site 3923); 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital ( Site 3909); 🇨🇳 Beijing, Beijing, China

Anhui Provincial Hospital ( Site 3947); 🇨🇳 Hefei, Anhui, China

Beijing Luhe Hospital Capital Medical University ( Site 3911); 🇨🇳 Beijing, Beijing, China

Chongqing University Three Gorges Hospital ( Site 3928); 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital Of Fujian Medical University ( Site 3904); 🇨🇳 Fuzhou, Fujian, China

The First Affiliated hospital of Xiamen University-Gastroenterology ( Site 3954); 🇨🇳 Xiamen, Fujian, China

Dongguan People's Hospital-Gastroenterology department ( Site 3944); 🇨🇳 Dongguan, Guangdong, China

Guangzhou Medical University 2nd Hospital ( Site 3908); 🇨🇳 Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital-Gastroenterology ( Site 3914); 🇨🇳 Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University ( Site 3906); 🇨🇳 Guangzhou, Guangdong, China

Huizhou Municipal Central Hospital ( Site 3917); 🇨🇳 Huizhou, Guangdong, China

Yuebei People's Hospital Guangdong ( Site 3948); 🇨🇳 Shaoguan, Guangdong, China

The University of Hong Kong-Shenzhen Hospital ( Site 3955); 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Hospital of Southern Medical University-Gastroenterology department ( Site 3905); 🇨🇳 Shenzhen, Guangdong, China

The Second Hospital of Hebei Medical University ( Site 3934); 🇨🇳 Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Zhengzhou University ( Site 3935); 🇨🇳 Zhengzhou, Henan, China

Taihe Hospital ( Site 3941); 🇨🇳 Shiyan, Hubei, China

The Central Hospital of Wuhan ( Site 3939); 🇨🇳 Wuhan, Hubei, China

Renmin Hospital of Wuhan University ( Site 3912); 🇨🇳 Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University ( Site 3930); 🇨🇳 Changsha, Hunan, China

Changzhou No.2 People's Hospital ( Site 3950); 🇨🇳 Changzhou, Jiangsu, China

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 3900); 🇨🇳 NanJing, Jiangsu, China

Zhongda Hospital Southeast University ( Site 3919); 🇨🇳 Nanjing, Jiangsu, China

Wuxi People's Hospital ( Site 3920); 🇨🇳 Wuxi, Jiangsu, China

The First Affiliated Hospital of Nanchang University ( Site 3926); 🇨🇳 Nanchang, Jiangxi, China

Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army ( Site 3929); 🇨🇳 Xian, Shaanxi, China

Binzhou Medical University Hospital ( Site 3953); 🇨🇳 Binzhou, Shandong, China

Taian City Central Hospital-gastroenterology department ( Site 3946); 🇨🇳 Taian, Shandong, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine-Gastroneterology ( Site 3903); 🇨🇳 Shanghai, Shanghai, China

Shanghai East Hospital ( Site 3922); 🇨🇳 Shanghai, Shanghai, China

Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 3915); 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University ( Site 3951); 🇨🇳 Cheng Du, Sichuan, China

Tianjin Medical University General Hospital ( Site 3945); 🇨🇳 Tianjin, Tianjin, China

The First Teaching Hospital of Xinjiang Medical University. ( Site 3937); 🇨🇳 Urumqi, Xinjiang, China

First Affiliated Hospital of Kunming Medical University ( Site 3925); 🇨🇳 Kunming, Yunnan, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-GI Medicine ( Site 3916); 🇨🇳 Hangzhou, Zhejiang, China

Clínica las Américas ( Site 2318); 🇨🇴 Medellín, Antioquia, Colombia

Clinica Medellin S.A ( Site 2317); 🇨🇴 Medellín, Antioquia, Colombia

Clinica Somer-Unidad de Investigacion y Docencia ( Site 2303); 🇨🇴 Rionegro, Antioquia, Colombia

Clinica de la Costa S.A.S. ( Site 2305); 🇨🇴 Barranquilla, Atlantico, Colombia

Fundacion Santa Fe de Bogota ( Site 2316); 🇨🇴 Bogota, Cundinamarca, Colombia

Oncologos del Occidente ( Site 2310); 🇨🇴 Pereira., Risaralda, Colombia

Fundación Valle del Lili ( Site 2307); 🇨🇴 Cali, Valle Del Cauca, Colombia

Klinička bolnica Merkur ( Site 0505); 🇭🇷 Zagreb, Grad Zagreb, Croatia

Klinički bolnički centar Zagreb ( Site 0501); 🇭🇷 Zagreb, Grad Zagreb, Croatia

Poliklinika Bates ( Site 0504); 🇭🇷 Zagreb, Grad Zagreb, Croatia

Poliklinika Solmed ( Site 0502); 🇭🇷 Zagreb, Grad Zagreb, Croatia

Poliklinika Borzan ( Site 0500); 🇭🇷 Osijek, Osjecko-baranjska Zupanija, Croatia

Klinički Bolnički Centar Split ( Site 0503); 🇭🇷 Split, Splitsko-dalmatinska Zupanija, Croatia

Institut Klinicke a Experimentalni Mediciny-Klinika hepatogastroentrologie ( Site 0604); 🇨🇿 Praha, Praha 4, Czechia

Nemocnice Slany ( Site 0601); 🇨🇿 Slany, Stredocesky Kraj, Czechia

Hepato-Gastroenterologie HK ( Site 0602); 🇨🇿 Hradec Kralove, Czechia

CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 3601); 🇩🇴 Santo Domingo, Distrito Nacional, Dominican Republic

Tampereen yliopistollinen sairaala ( Site 4300); 🇫🇮 Tampere, Pirkanmaa, Finland

Pohjois-Karjalan keskussairaala ( Site 4302); 🇫🇮 Joensuu, Pohjois-Karjala, Finland

Turku University Hospital ( Site 4301); 🇫🇮 Turku, Varsinais-Suomi, Finland

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0706); 🇫🇷 Nice, Alpes-Maritimes, France

CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0700); 🇫🇷 Pessac, Aquitaine, France

Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0714); 🇫🇷 Marseille, Bouches-du-Rhone, France

CHU Besançon ( Site 0710); 🇫🇷 Besançon, Doubs, France

Hopital Beaujon ( Site 0716); 🇫🇷 Clichy, Hauts-de-Seine, France

CHU SAINT ELOI ( Site 0711); 🇫🇷 Montpellier, Languedoc-Roussillon, France

Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré ( Site 0705); 🇫🇷 Reims, Champagne-Ardenne, France

C.H.U. de Nimes. Hopital Caremeau ( Site 0718); 🇫🇷 Nimes, Gard, France

CMC Ambroise Paré Hartmann - Institut des MICI ( Site 0709); 🇫🇷 Neuilly-sur-Seine, Hauts-de-Seine, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 0701); 🇫🇷 Nantes, Loire-Atlantique, France

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois ( Site 0708); 🇫🇷 Vandoeuvre lès Nancy, Meurthe-et-Moselle, France

centre hospitalier lyon sud ( Site 0707); 🇫🇷 Pierre-Bénite, Rhone, France

CHU d'Amiens-Picardie - Hôpital Sud-Hepato-gastroentérology ( Site 0712); 🇫🇷 Amiens, Somme, France

Hopital Henri Mondor ( Site 0717); 🇫🇷 Creteil, Val-de-Marne, France

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0715); 🇫🇷 Le Kremlin-Bicêtre, Val-de-Marne, France

Hôpital Saint Antoine ( Site 0703); 🇫🇷 Paris, France

Hôpital Saint-Louis ( Site 0702); 🇫🇷 Paris, France

Caraps Medline ( Site 0803); 🇬🇪 Tbilisi, Georgia

New Hospitals ( Site 0800); 🇬🇪 Tbilisi, Georgia

Caucasus Medical Centre ( Site 0801); 🇬🇪 Tbilisi, Georgia

Universitaetsklinikum Ulm. ( Site 0902); 🇩🇪 Ulm, Baden-Wurttemberg, Germany

Klinikum der Universität München Großhadern-Medizinische Klinik und Poliklinik II ( Site 0907); 🇩🇪 Munich, Bayern, Germany

Agaplesion Markus Krankenhaus ( Site 0904); 🇩🇪 Frankfurt am Main, Hessen, Germany

Medizinische Hochschule Hannover ( Site 0913); 🇩🇪 Hannover, Niedersachsen, Germany

Klinikum Lüneburg ( Site 0908); 🇩🇪 Lüneburg, Niedersachsen, Germany

Stadtische Kliniken Duisburg, Abtlg. Innere Medizin ( Site 0916); 🇩🇪 Duisburg, Nordrhein-Westfalen, Germany

Gastroenterologische Gemeinschaftspraxis Minden ( Site 0911); 🇩🇪 Minden, Nordrhein-Westfalen, Germany

Medizinisches Versorgungszentrum Portal 10 ( Site 0914); 🇩🇪 Münster, Nordrhein-Westfalen, Germany

St. Marien und St. Annastift Krankenhaus ( Site 0901); 🇩🇪 Ludwighafen Am Rhein, Rheinland-Pfalz, Germany

Universitätsklinikum Leipzig ( Site 0909); 🇩🇪 Leipzig, Sachsen, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0903); 🇩🇪 Kiel, Schleswig-Holstein, Germany

Charité Campus Virchow-Klinikum ( Site 0906); 🇩🇪 Berlin, Germany

Städtisches Klinikum Brandenburg ( Site 0905); 🇩🇪 Brandenburg, Germany

Evangelismos General Hospital of Athens ( Site 4001); 🇬🇷 Athens, Attiki, Greece

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol ( Site 4000); 🇬🇷 Athens, Attiki, Greece

General Hospital of Nikaia-Piraeus "Agios Panteleimon" ( Site 4006); 🇬🇷 Nikaia Piraeus, Attiki, Greece

Ippokrateio General Hospital of Thessaloniki ( Site 4004); 🇬🇷 Thessaloniki, Kentriki Makedonia, Greece

University General Hospital of Heraklion-GASTROENTEROLOGY & HEPATOLOGY ( Site 4003); 🇬🇷 Heraklion, Kriti, Greece

Csőszi Endoszkópos KFT ( Site 1001); 🇭🇺 Kecskemét, Bacs-Kiskun, Hungary

Mohácsi Kórház ( Site 1008); 🇭🇺 Mohács, Baranya, Hungary

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1007); 🇭🇺 Békéscsaba, Bekescsaba, Hungary

Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1012); 🇭🇺 Eger, Heves, Hungary

Gyöngyösi Bugát Pál Kórház ( Site 1011); 🇭🇺 Gyongyos, Heves, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz ( Site 1010); 🇭🇺 Tatabánya, Komarom-Esztergom, Hungary

VeszLife Magánklinika ( Site 1002); 🇭🇺 Veszprém, Veszprem, Hungary

Synexus Magyarorszag Kft. (Budapest DRS) ( Site 1009); 🇭🇺 Budapest, Hungary

Semmelweis Egyetem ( Site 1006); 🇭🇺 Budapest, Hungary

Pannónia Magánorvosi Centrum ( Site 1004); 🇭🇺 Budapest, Hungary

Emek Medical Center ( Site 1106); 🇮🇱 Afula, Israel

Barzilai Medical Center ( Site 1109); 🇮🇱 Ashkelon, Israel

Rambam Health Care Campus ( Site 1101); 🇮🇱 Haifa, Israel

Bnai Zion Medical Center ( Site 1103); 🇮🇱 Haifa, Israel

Edith Wolfson Medical Center ( Site 1104); 🇮🇱 Holon, Israel

Shaare Zedek Medical Center ( Site 1108); 🇮🇱 Jerusalem, Israel

Meir Medical Center. ( Site 1102); 🇮🇱 Kfar Saba, Israel

Rabin Medical Center ( Site 1107); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center ( Site 1100); 🇮🇱 Ramat Gan, Israel

Policlinico Universitario Monserrato-SC Gastroenterologia ( Site 1207); 🇮🇹 Monserrato, Cagliari, Italy

IRCCS Casa Sollievo della Sofferenza ( Site 1213); 🇮🇹 San Giovanni Rotondo, Foggia, Italy

Fondazione Policlinico Tor Vergata ( Site 1209); 🇮🇹 Rome, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Gastroenterology and Endoscopy Unit ( Site 1202); 🇮🇹 Milano, Lombardia, Italy

Istituto Clinico Humanitas-IBD center ( Site 1201); 🇮🇹 Rozzano, Lombardia, Italy

Ospedale Di Circolo-U.O.C. di Gastroenterologia ed Endoscopia Digestiva ( Site 1216); 🇮🇹 Rho, Milano, Italy

A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 1217); 🇮🇹 Napoles, Napoli, Italy

Azienda Ospedaliera San Camillo Forlanini ( Site 1204); 🇮🇹 Rome, Roma, Italy

Fatebenefratelli Isola Tiberina - Gemelli Isola ( Site 1214); 🇮🇹 Rome, Roma, Italy

Az. Osp. Ospedali Riuniti VILLA SOFIA-CERVELLO-U.O.S.D. Malattie Infiammatorie Croniche Intestinali ( Site 1210); 🇮🇹 Palermo, Sicilia, Italy

Ospedale Sacro Cuore Don G. Calabria ( Site 1212); 🇮🇹 Negrar, Verona, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1208); 🇮🇹 Bologna, Italy

ASST Fatebenefratelli Sacco-UOC Gastroenterologia ( Site 1200); 🇮🇹 Milano, Italy

Ospedale San Raffaele-Gastroenterology and Gastrointestinal Endoscopy ( Site 1205); 🇮🇹 Milano, Italy

Fondazione IRCCS Policlinico San Matteo-General Medicine ( Site 1206); 🇮🇹 Pavia, Italy

Aichi Medical University Hospital ( Site 2841); 🇯🇵 Nagakute, Aichi, Japan

Tokatsu Tsujinaka Hospital ( Site 2832); 🇯🇵 Abiko, Chiba, Japan

Tsujinaka Hospital - Kashiwanoha ( Site 2802); 🇯🇵 Kashiwa, Chiba, Japan

Toho University Sakura Medical Center ( Site 2805); 🇯🇵 Sakura, Chiba, Japan

Ehime Prefectural Central Hospital ( Site 2868); 🇯🇵 Matsuyama, Ehime, Japan

Kitakyushu Municipal Medical Center ( Site 2873); 🇯🇵 Kitakyushu, Fukuoka, Japan

Kurume University Hospital ( Site 2846); 🇯🇵 Kurume, Fukuoka, Japan

Gunma University Hospital ( Site 2850); 🇯🇵 Maebashi, Gunma, Japan

National Hospital Organization Fukuyama Medical Center ( Site 2831); 🇯🇵 Fukuyama, Hiroshima, Japan

Asahikawa City Hospital ( Site 2840); 🇯🇵 Asahikawa, Hokkaido, Japan

Asahikawa Medical University Hospital ( Site 2815); 🇯🇵 Asahikawa, Hokkaido, Japan

Sapporo Tokushukai Hospital ( Site 2808); 🇯🇵 Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital ( Site 2829); 🇯🇵 Sapporo, Hokkaido, Japan

Medical Corporation Sapporo IBD Clinic ( Site 2842); 🇯🇵 Sapporo, Hokkaido, Japan

Sapporohigashi Tokushukai Hospital ( Site 2860); 🇯🇵 Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital ( Site 2830); 🇯🇵 Nishinomiya, Hyogo, Japan

Hitachi General Hospital ( Site 2856); 🇯🇵 Hitachi, Ibaraki, Japan

Ishikawa Prefectural Central Hospital ( Site 2835); 🇯🇵 Kanazawa, Ishikawa, Japan

Kanazawa University Hospital ( Site 2839); 🇯🇵 Kanazawa, Ishikawa, Japan

Iwate Medical University Uchimaru Medical Center ( Site 2833); 🇯🇵 Morioka, Iwate, Japan

Gokeikai Ofuna Chuo Hospital ( Site 2801); 🇯🇵 Kamakura, Kanagawa, Japan

St. Marianna University Hospital ( Site 2852); 🇯🇵 Kawasaki, Kanagawa, Japan

Matsushima Hospital ( Site 2822); 🇯🇵 Yokohama, Kanagawa, Japan

Yokohama City University Medical Center ( Site 2865); 🇯🇵 Yokohama, Kanagawa, Japan

Mie University Hospital ( Site 2838); 🇯🇵 Tsu, Mie, Japan

Sai Gastroenterology/Proctology Clinic ( Site 2814); 🇯🇵 Fujiidera, Osaka, Japan

Kansai Medical University Hospital ( Site 2823); 🇯🇵 Hirakata, Osaka, Japan

Hamamatsu University Hospital ( Site 2874); 🇯🇵 Hamamatsu, Shizuoka, Japan

Matsuda Hospital ( Site 2826); 🇯🇵 Hamamatsu, Shizuoka, Japan

National Hospital Organization Shizuoka Medical Center ( Site 2837); 🇯🇵 Shimizu, Shizuoka, Japan

Institute of Science Tokyo Hospital ( Site 2827); 🇯🇵 Bunkyō, Tokyo, Japan

Ginza Central Clinic ( Site 2824); 🇯🇵 Chuo, Tokyo, Japan

Toranomon Hospital ( Site 2828); 🇯🇵 Minato-ku, Tokyo, Japan

Kitasato University Kitasato Institute Hospital ( Site 2817); 🇯🇵 Minato-ku, Tokyo, Japan

The Jikei University Hospital ( Site 2843); 🇯🇵 Minato, Tokyo, Japan

Kyorin University Hospital ( Site 2804); 🇯🇵 Mitaka-shi, Tokyo, Japan

NTT Medical Center Tokyo ( Site 2834); 🇯🇵 Shinagawa-ku, Tokyo, Japan

Yamanashi Prefectural Central Hospital ( Site 2836); 🇯🇵 Kofu, Yamanashi, Japan

Fukui Prefectural Hospital ( Site 2844); 🇯🇵 Fukui, Japan

Fukuoka University Hospital ( Site 2818); 🇯🇵 Fukuoka, Japan

Hiroshima University Hospital ( Site 2845); 🇯🇵 Hiroshima, Japan

Kagoshima University Hospital ( Site 2848); 🇯🇵 Kagoshima, Japan

Kagoshima IBD Gastroenterology Clinic ( Site 2821); 🇯🇵 Kagoshima, Japan

University Hospital,Kyoto Prefectural University of Medicine ( Site 2819); 🇯🇵 Kyoto, Japan

National Hospital Organization Kyoto Medical Center ( Site 2813); 🇯🇵 Kyoto, Japan

Ishida Clinic of IBD and Gastroenterology ( Site 2820); 🇯🇵 Oita, Japan

Okayama University Hospital ( Site 2870); 🇯🇵 Okayama, Japan

Infusion Clinic ( Site 2806); 🇯🇵 Osaka, Japan

National Hospital Organization Osaka National Hospital ( Site 2869); 🇯🇵 Osaka, Japan

Saga University Hospital ( Site 2812); 🇯🇵 Saga, Japan

Tokitokai Tokito Clinic Coloproctology Center ( Site 2811); 🇯🇵 Saitama, Japan

Tokyo Yamate Medical Center ( Site 2803); 🇯🇵 Tokyo, Japan

Toyama Prefectural Central Hospital ( Site 2807); 🇯🇵 Toyama, Japan

Yamagata University Hospital ( Site 2849); 🇯🇵 Yamagata, Japan

Wonju Severance Christian Hospital-Internal Medicine ( Site 3003); 🇰🇷 Wonju, Kang-won-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital-Gastroenterology ( Site 3006); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Dong-A University Hospital ( Site 3010); 🇰🇷 Busan, Pusan-Kwangyokshi, Korea, Republic of

Inje University Haeundae Paik Hospital ( Site 3009); 🇰🇷 Haeundae-gu, Pusan-Kwangyokshi, Korea, Republic of

Chung-Ang University Hospital ( Site 3008); 🇰🇷 Dongjak-gu, Seoul, Korea, Republic of

Yeungnam University Medical Center ( Site 3004); 🇰🇷 Daegu, Taegu-Kwangyokshi, Korea, Republic of

The Catholic University of Korea, Daejeon St. Mary's Hospital ( Site 3011); 🇰🇷 Daejeon, Taejon-Kwangyokshi, Korea, Republic of

Kyung Hee University Hospital ( Site 3013); 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital ( Site 3005); 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital-Internal Medicine ( Site 3002); 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3012); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Department of Internal Medicine ( Site 3000); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center ( Site 3007); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center ( Site 3001); 🇰🇷 Seoul, Korea, Republic of

SIA M & M Centrs ( Site 4502); 🇱🇻 Adazi, Adazu Novads, Latvia

Liepaja Regional Hospital ( Site 4501); 🇱🇻 Liepaja, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 4600); 🇱🇹 Kaunas, Kauno Apskritis, Lithuania

VUL SANTAROS KLINIKOS ( Site 4601); 🇱🇹 Vilnius, Vilniaus Miestas, Lithuania

Morales Vargas Centro de Investigacion ( Site 2411); 🇲🇽 León, Guanajuato, Mexico

PanAmerican Clinical Research - Guadalajara ( Site 2400); 🇲🇽 Guadalajara, Jalisco, Mexico

Centro Medico Clinico Quirurgico Especializado en Investigación ( Site 2403); 🇲🇽 Tlajumulco De Zuniga, Jalisco, Mexico

Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan ( Site 2407); 🇲🇽 Merida, Yucatan, Mexico

ICARO Investigaciones en Medicina ( Site 2405); 🇲🇽 Chihuahua, Mexico

Centro de Investigación y Gastroenterología - S.C. ( Site 2410); 🇲🇽 Mexico City, Mexico

Oaxaca Site Management Organization S.C. ( Site 2404); 🇲🇽 Oaxaca, Mexico

Radboudumc ( Site 1402); 🇳🇱 Nijmegen, Gelderland, Netherlands

ETZ Elisabeth-Department of Gastroenterology and Hepatology ( Site 1403); 🇳🇱 Tilburg, Noord-Brabant, Netherlands

Ziekenhuis Bernhoven-Researchbureau ( Site 1401); 🇳🇱 Uden, Noord-Brabant, Netherlands

Onze Lieve Vrouwe Gasthuis ( Site 1405); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Amsterdam UMC, locatie VUmc-IBD Trial Unit ( Site 1400); 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Deventer Ziekenhuis ( Site 1411); 🇳🇱 Deventer, Overijssel, Netherlands

Erasmus Medisch Centrum ( Site 1410); 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Franciscus Gasthuis & Vlietland, Locatie Gasthuis ( Site 1406); 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Universitair Medisch Centrum Utrecht ( Site 1404); 🇳🇱 Utrecht, Netherlands

Waikato Hospital ( Site 2903); 🇳🇿 Hamilton, Waikato, New Zealand

Hutt Valley District Health board HVDHB ( Site 2902); 🇳🇿 Lower Hutt, Wellington, New Zealand

Aotearoa Clinical Trials ( Site 2900); 🇳🇿 Auckland, New Zealand

Akershus Universitetssykehus ( Site 4200); 🇳🇴 Lørenskog, Akershus, Norway

Oslo Universitetssykehus Ullevål ( Site 4201); 🇳🇴 Oslo, Norway

Planetmed ( Site 1506); 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Melita Medical ( Site 1519); 🇵🇱 Wroclaw, Dolnoslaskie, Poland

EMC Instytut Medyczny SA ( Site 1505); 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Gastromed Sp. z o. o. ( Site 1513); 🇵🇱 Torun, Kujawsko-pomorskie, Poland

Med-Gastr Sp. z o.o., sp.k ( Site 1515); 🇵🇱 Lodz, Lodzkie, Poland

AmiCare Centrum Medyczne - Zgierska ( Site 1517); 🇵🇱 Lodz, Lodzkie, Poland

Allmedica ( Site 1508); 🇵🇱 Nowy Targ, Malopolskie, Poland

Vivamed Sp. z o.o. ( Site 1510); 🇵🇱 Warsawa, Mazowieckie, Poland

Centrum Zdrowia MDM ( Site 1512); 🇵🇱 Warszawa, Mazowieckie, Poland

WIP Warsaw IBD Point Profesor Kierkuś ( Site 1503); 🇵🇱 Warszawa, Mazowieckie, Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 1502); 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Sonomed Sp. z o. o. ( Site 1516); 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 3306); 🇵🇹 Lisbon, Lisboa, Portugal

Unidade Local de Saude de Braga - Hospital de Braga ( Site 3300); 🇵🇹 Braga, Portugal

Hospital dos Lusíadas Lisboa ( Site 3303); 🇵🇹 Lisboa, Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3305); 🇵🇹 Lisboa, Portugal

ULSAM - Hospital de Santa Luzia ( Site 3302); 🇵🇹 Viana do Castelo, Portugal

Unidade Local de Saude Dão-Lafões - Hospital de São Teotónio ( Site 3308); 🇵🇹 Viseu, Portugal

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 1606); 🇷🇴 Bucharest, Bucuresti, Romania

Fundeni Clinical Institute-Gastroenterology and Hepatology Center ( Site 1608); 🇷🇴 București, Bucuresti, Romania

Spitalul Clinic Judetean de Urgenta Cluj Napoca-Gastroenterology ( Site 1605); 🇷🇴 Cluj Napoca, Cluj, Romania

GastroMed ( Site 1609); 🇷🇴 Cluj-Napoca, Cluj, Romania

Spitalul Clinic Judetean Mures-Gastroenterology ( Site 1607); 🇷🇴 Targu Mures, Mures, Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L-Gastroenterology ( Site 1601); 🇷🇴 Timisoara, Timis, Romania

S.C. Centrul Medical Medicum SRL-Gastroenterology ( Site 1604); 🇷🇴 Bucuresti, Romania

Clinical Hospital Center Dragisa Misovic ( Site 1708); 🇷🇸 Belgrade, Beograd, Serbia

Clinical Hospital Center Zvezdara-Gastroenterology and hepatology Department ( Site 1705); 🇷🇸 Belgrade, Beograd, Serbia

University Medical Center "Bezanijska kosa"-Gastroenterology and hepatology ( Site 1704); 🇷🇸 Belgrade, Beograd, Serbia

Clinical Center Kragujevac ( Site 1703); 🇷🇸 Kragujevac, Beograd, Serbia

General Hospital "Djordje Joanovic" ( Site 1707); 🇷🇸 Zrenjanin, Srednjebanatski Okrug, Serbia

Breznianske centrum gastroenterologie ( Site 1806); 🇸🇰 Brezno, Banskobystricky Kraj, Slovakia

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 1802); 🇸🇰 Slovakia, Banskobystricky Kraj, Slovakia

Cliniq s.r.o. ( Site 1800); 🇸🇰 Bratislava, Bratislavsky Kraj, Slovakia

ENDOMED ( Site 1801); 🇸🇰 Kosice, Kosicky Kraj, Slovakia

KM Management ( Site 1804); 🇸🇰 Nitra, Nitriansky Kraj, Slovakia

Accout Center ( Site 1805); 🇸🇰 Sahy, Nitriansky Kraj, Slovakia

Wits Clinical Research-Research ( Site 3208); 🇿🇦 Johannesburg, Gauteng, South Africa

Wits Clinical Research-Wits Clinical Research Bara ( Site 3206); 🇿🇦 Soweto, Gauteng, South Africa

Panorama Medical Centre ( Site 3209); 🇿🇦 Cape Town, Western Cape, South Africa

Spoke Research ( Site 3210); 🇿🇦 Cape Town, Western Cape, South Africa

Life Kingsbury Hospital ( Site 3203); 🇿🇦 Cape Town, Western Cape, South Africa

Private Practice - Dr. M.N. Rajabally ( Site 3213); 🇿🇦 Cape Town, Western Cape, South Africa

Hospital Germans Trias i Pujol ( Site 3413); 🇪🇸 Badalona, Barcelona, Spain

Hospital Universitari Mutua Terrassa ( Site 3416); 🇪🇸 Terrassa, Barcelona, Spain

Hospital Galdakao-Usansolo ( Site 3409); 🇪🇸 Galdakao-Usansolo, Bizkaia, Spain

Hospital La Princesa-Gastroenterology ( Site 3411); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Fundación Jimenez Diaz ( Site 3420); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital Universitario de Torrejon ( Site 3417); 🇪🇸 Torrejón de Ardoz, Madrid, Comunidad De, Spain

Hospital Universitario de Fuenlabrada-Digestive ( Site 3415); 🇪🇸 Fuenlabrada, Madrid, Spain

HOSPITAL CLINICO DE VALENCIA ( Site 3406); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Hospital Universitari i Politecnic La Fe-Enfermedad Inflamatoria Intestinal ( Site 3405); 🇪🇸 València, Valencia, Spain

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Aparato Digestivo ( Site 3403); 🇪🇸 Madrid, Spain

Hospital Universitario La Paz-Unidad de Enfermedad Inflamatoria Intestinal ( Site 3402); 🇪🇸 Madrid, Spain

INTESTO-Gastroenterologische Praxis / Crohn-Colitis Zentrum Bern ( Site 1902); 🇨🇭 Bern, Berne, Switzerland

Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 1901); 🇨🇭 St.Gallen, Sankt Gallen, Switzerland

UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 1900); 🇨🇭 Zürich, Zurich, Switzerland

Changhua Christian Hospital ( Site 3104); 🇨🇳 Changhua County, Changhua, Taiwan

National Taiwan University BioMedical Park Hospital ( Site 3103); 🇨🇳 Zhu Bei City, Hsinchu, Taiwan

China Medical University Hospital ( Site 3100); 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital ( Site 3102); 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 3101); 🇨🇳 Taoyuan, Taiwan

Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3503); 🇹🇷 Istanbul- Fatih, Istanbul, Turkey

ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 3507); 🇹🇷 Ankara, Turkey

Hacettepe Universite Hastaneleri ( Site 3500); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Gastroenterology ( Site 3501); 🇹🇷 Ankara, Turkey

Antalya Egitim ve Arastirma Hastanesi ( Site 3508); 🇹🇷 Antalya, Turkey

Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 3505); 🇹🇷 Istanbul, Turkey

Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 4115); 🇺🇦 Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine

Center of Family Medicine Plus-Treatment Prevention Unit ( Site 4103); 🇺🇦 Kyiv, Kyivska Oblast, Ukraine

Communal Non-profit Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"-proctology ( Site 4109); 🇺🇦 Lviv, Lvivska Oblast, Ukraine

Limited liability company "Medical center Health Clinic"-Gastroenterology, Hepatology and Endocrino ( Site 4107); 🇺🇦 Vinnytsia, Vinnytska Oblast, Ukraine

Communal Non-Commercial Enterprise "Vinnytsia City Clinical -Clinical Therapeutic Department #1 ( Site 4111); 🇺🇦 Vinnytsia, Vinnytska Oblast, Ukraine

Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical -Gastroenterology department ( Site 4114); 🇺🇦 Vinnytsya, Vinnytska Oblast, Ukraine

Municipal Enterprise "Volyn Regional Clinical Hospital" of V-surgery department (abdominal, colopro ( Site 4113); 🇺🇦 Lutsk, Volynska Oblast, Ukraine

Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 4100); 🇺🇦 Kyiv, Ukraine

Dobrobut Medical Center ( Site 4101); 🇺🇦 Kyiv, Ukraine

Medical Center of Private Enterprise "Sygma" ( Site 4108); 🇺🇦 Kyiv, Ukraine

Southmead Hospital ( Site 2004); 🇬🇧 Bristol, Bristol, City Of, United Kingdom

Addenbrooke's Hospital ( Site 2005); 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Royal Devon & Exeter Hospital-IBD Research Group ( Site 2001); 🇬🇧 Exeter, Devon, United Kingdom

Doncaster Royal Infirmary ( Site 2006); 🇬🇧 Doncaster, England, United Kingdom

Huddersfield Royal Infirmary ( Site 2010); 🇬🇧 Huddersfield, England, United Kingdom

Whipps Cross University Hospital-Clinical Research Unit ( Site 2000); 🇬🇧 London, England, United Kingdom

St. George's Hospital ( Site 2007); 🇬🇧 London, England, United Kingdom

Southampton General Hospital-Gastroenterology ( Site 2003); 🇬🇧 Southampton, Hampshire, United Kingdom

University College London Hospital-Clinical Research Facility ( Site 2002); 🇬🇧 London, London, City Of, United Kingdom

Walsall Manor Hospital ( Site 2009); 🇬🇧 West Midlands, Walsall, United Kingdom