Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet

Phase 2

Recruiting

• Conditions: Celiac Disease
• Interventions: Drug: Placebo; Drug: TAK-101; Dietary Supplement: Gluten

• Registration Number: NCT04530123
• Lead Sponsor: Takeda

Brief Summary

The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).

Participants will receive TAK-101 and/or placebo through the vein on Day 1 and Day 8. All participants will receive active treatment at Week 24.

Detailed Description

The drug being tested in this study is called TAK-101. TAK-101 is being tested to treat people who have celiac disease. The study has two cohorts planned. The first cohort has 1 dose level and the second cohort may include 1 or 2 dose levels, depending on safety, tolerability, and activity observed in the first cohort. Dosing in the second cohort will be based on data from the initial cohort.

The study will enrol approximately 108 patients (18 per arm). In the first cohort, approximately 45 participants will be randomly assigned in 1:2:2 ratio in one of the three arm groups which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Eligible participants in Cohort 1 will receive:

* Group A: 2 infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.

* Group B: 1 infusion dose of 2 mg/kg of TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.

* Group C: 2 infusion doses of 2 mg/kg of TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.

After the review of Cohort 1 safety data, a decision will be made to either stop the study or continue the study by the sponsor safety management team (SMT), based on recommendations from independent data monitoring committee (IDMC). If it is deemed appropriate to enroll both the TAK-101 4 mg/kg and 1 mg/kg dose level, approximately 63 participants may be randomly assigned in 1:2:2:2 ratio in Cohort 2 to receive:

* Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 2 mg/kg TAK-101 at Week 24.

* Group E: One infusion dose of 4 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.

* Group F: Two infusion doses of 4mg/kg, 1 on Day 1 and 1 on day 8, followed by 1 infusion dose of 4 mg/kg TAK-101 at Week 24.

* Group G: TAK-101 1 mg/kg: Two infusion doses of 1 mg/kg TAK-101, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24 (1 mg/kg may not be needed based on review of Cohort 1 data).

In Cohort 2 if the 1 mg/kg treatment arm is not needed, Cohort 2 will consist of 45 participants in total, being randomized in a 1:2:2 ratio to 1 of the 3 treatment groups (Groups D, E, F) listed above.

If it is decided not to open the second cohort at the 4 mg/kg dose level and if 1 mg/kg dose is recommended to be tested by the IDMC, approximately 45 participants will be randomly assigned in 1:2:2 ratio to receive:

* Group D: Two infusion doses of placebo, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.

* Group E: One infusion dose of 1 mg/kg TAK-101 on Day 1 followed by 1 infusion dose of placebo on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.

* Group F: Two infusion doses of 1 mg/kg, 1 on Day 1 and 1 on Day 8, followed by 1 infusion dose of 1 mg/kg TAK-101 at Week 24.

This trial will be conducted in United States and Canada. The overall time to participate in this study is approximately 24 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone OR plus a final visit after receiving their last dose of study drug for a follow-up assessment.

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2022-06-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Biopsy-confirmed CeD that is well-controlled, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD and with immunoglobulin A (IgA) tissue transglutaminase (tTG) <2 × upper limit of normal (ULN) and IgG deamidated gliadin peptide (DGP) <3 × ULN.

   Note: Participants may be retested for IgA tTG and IgG DGP to meet eligibility criteria at the discretion of the investigator. Intermittent symptoms would not exclude participants from participation as long as symptoms are generally well controlled in the opinion of the investigator, and as long as symptoms are back to baseline for 2 weeks before the run-in gluten challenge.

2. Must be attempting to maintain a gluten-free diet (GFD) for ≥6 months.

3. Must be HLA-DQ2 and/or HLA-DQ8 positive during screening laboratory testing.

Read More

Exclusion Criteria

1. Has received any investigational compound within 12 weeks (84 days) before signing of the informed consent or during the current study.
2. Has received TAK-101 (TIMP-GLIA) in a previous clinical study or as a therapeutic agent.
3. Has presence of inflammatory gastrointestinal disorders or autoimmune diseases, other than well-controlled autoimmune thyroid disease or well-controlled type 1 diabetes mellitus (defined as glycosylated hemoglobin <8% and no hospitalization in the last 12 months for hyper/hypoglycemia).
4. Has known or suspected refractory CeD or ulcerative jejunitis.
5. Has additional food allergies or intolerances that prevent participation in the food challenge.
6. Is receiving ongoing systemic immunosuppressant, systemic (oral or IV) corticosteroid treatment, or has received treatment with systemic immunosuppressants or corticosteroids in the 12 weeks before run-in gluten challenge.
7. Has known or suspected chronic liver disease or positive for hepatitis B or C.
8. Has intolerable symptoms after the run-in gluten challenge and is unwilling to undergo subsequent posttreatment gluten challenges.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	Placebo	Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	TAK-101	Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	Gluten	Following a single-day 3 gram (g) oral run-in gluten challenge, participants will receive TAK-101 placebo-matching intravenous (IV) infusion dose, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 microgram per kilogram (µg/kg) GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE	Placebo	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group B: TAK-101 25 µg/kg GE + Placebo + TAK-101 25 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg, IV infusion once on Day 1 followed by TAK-101 placebo-matching IV infusion, once on Day 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 1, Group C: TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE + TAK-101 25 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 25 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24.
Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	Placebo	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group A: Placebo + Placebo + TAK-101 25 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 25 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group D: TAK-101 50 µg/kg GE + TAK-101 50 µg/kg GE+ TAK-101 50 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 50 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 50 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE	Placebo	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level.
Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level.
Cohort 2, Group E: Placebo + Placebo + TAK-101 12.5 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 placebo-matching IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1. This group would be opened only if it is decided not to open Cohort 2 at the 50 µg/kg GE dose level.
Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE	TAK-101	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.
Cohort 2, Group F: TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE + TAK-101 12.5 µg/kg GE	Gluten	Following a single-day 3 g oral run-in gluten challenge, participants will receive TAK-101 12.5 µg/kg GE IV infusion, once each on Days 1 and 8, followed by 12 g/day gluten for 3 days followed by 6 g/day gluten for 3 days starting at Week 2. Participants will then undergo single-day 3 g gluten challenges at Weeks 8, 14, and 20. A third IV infusion dose of TAK-101 12.5 µg/kg GE will be given 23 weeks after the second dose at approximately Week 24. Cohort 2 would start based on the results of Cohort 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Interferon-gamma Spot Forming Units (IFN-γ SFUs) in Human Leukocyte Antigens Density Quotient (HLA-DQ2.5-positive) Participants Based on Results of a Gliadin-Specific Enzyme-Linked Immunospot (ELISpot) Assay	Baseline (Day 15, or Day 1 in the absence of Day 15) to Week 3 (Day 20)	IFN-γ SFUs will be measured based on results of a gliadin-specific ELISpot assay using gluten-specific T cells which will be isolated from blood.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing at Least One Adverse Event (AE) and Adverse Events of Special Interest (AESIs)	From the first IV dose up to 30 days after last IV dose (Up to Week 28)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a markedly abnormal physical examination finding, vital sign value, laboratory test value), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. An AESI (serious or nonserious) is one of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor may be appropriate.
Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change of the 3-day Average Nausea Severity Score as Measured in Celiac Disease Symptom Diary (CDSD)	Run-in (Visit 2), Weeks 8, 14, and 20	The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the celiac disease (CeD) symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. For Weeks 8, 14, and 20, it is calculated as the average of the available daily scores recorded in the 3 days prior and after the respective gluten challenge.
Change From Run-in (Visit 2) to Weeks 8,14, and 20 in the Pre- to Post-gluten Challenge Change in CDSD 3-day Peak Nausea Severity Score	Run-in (Visit 2), Weeks 8, 14, and 20	The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. The scores from the past 3 days with a 24-hour recall period will be averaged. Peak score is the highest score in the 3 days prior and following gluten challenge at Weeks 8, 14, and 20.
Change From Run-in (Visit 2) to Weeks 8, 14, and 20 in the Pre- to Post-gluten Challenge Change in Weekly Gastrointestinal (GI) Symptom Severity Score	Run-in (Visit 2), Weeks 8, 14, and 20	The CDSD version 2.1 is an 8-item, self-administered questionnaire that evaluates the CeD symptoms using 5-point Likert-type scales, where lower score indicating no symptoms and higher score indicating severe symptoms for all items except for frequency questions relating to stool counts, diarrhea, and vomiting frequency. GI symptom severity score ranges from 0 to 20 with higher score indicating more severe disease.
Fold Change in Plasma Interleukin-2 (IL-2) from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20	Pre-/post-gluten challenge at Run-in (Visit 2), Day 15, and Weeks 8, 14, and 20	The pre-/post-gluten challenge fold change in plasma IL-2 from Run-in (Visit 2) to Day 15, and Weeks 8, 14, and 20 will be compared.
Fold Change in Plasma IL-2 at Specified Time Points	Pre-/post-gluten challenge at Run-in (Visit 2), Day 15, and Weeks 8, 14, and 20	The pre-/post-gluten challenge fold change in plasma IL-2 at each of the time points will be compared.
Plasma Concentration of TAK-101 After Each Dose	Predose and postdose at Weeks 0, 1 and 24
Serum Concentration of Antidrug Antibody (ADAs) to Various Doses of TAK-101	Predose at Week 1 and before gluten challenge at Weeks 2, 14, 20, and 24	ADA includes deamidated gliadin peptide- immunoglobulin G (DGP- IgG).

Trial Locations

Locations (82)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

One of a Kind Clinical Research Center LLC; 🇺🇸 Scottsdale, Arizona, United States

Precision Research Institute, LLC; 🇺🇸 Chula Vista, California, United States

Gastroenterology and Liver Institute; 🇺🇸 Escondido, California, United States

Care Access Research Los Gatos; 🇺🇸 Los Gatos, California, United States

California Medical Research Associates Inc.; 🇺🇸 Northridge, California, United States

Asthma and Allergy Associates, PC; 🇺🇸 Colorado Springs, Colorado, United States

Gastro Florida; 🇺🇸 Clearwater, Florida, United States

Sweet Hope Research Specialty, Inc.; 🇺🇸 Hialeah, Florida, United States

Wellness Clinical Research; 🇺🇸 Miami Lakes, Florida, United States

GCP Clinical Research, LLC; 🇺🇸 Tampa, Florida, United States

Agile Clinical Research Trials; 🇺🇸 Atlanta, Georgia, United States

Lemah Creek Clinical Research; 🇺🇸 Oakbrook Terrace, Illinois, United States

Rockford Gastroenterology Associates, Ltd.; 🇺🇸 Rockford, Illinois, United States

Gastroenterology Health Partners, PLLC; 🇺🇸 New Albany, Indiana, United States

University Medical Center New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Boston Specialists; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Lahey Clinic Inc. - PARENT ACCOUNT; 🇺🇸 Burlington, Massachusetts, United States

Berkshire Medical Center; 🇺🇸 Pittsfield, Massachusetts, United States

Clinical Research Institute of Michigan, LLC; 🇺🇸 Chesterfield, Michigan, United States

Revive Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

Albuquerque Clinical Trials, Inc.; 🇺🇸 Albuquerque, New Mexico, United States

Columbia University; 🇺🇸 New York, New York, United States

Javara Inc; 🇺🇸 Charlotte, North Carolina, United States

Medication Management, LLC; 🇺🇸 Greensboro, North Carolina, United States

East Carolina Gastroenterology, PA; 🇺🇸 Jacksonville, North Carolina, United States

Wellnow Urgent Care and Research; 🇺🇸 Cincinnati, Ohio, United States

Gastro Health Research; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic - Gastroenterology and Hepatology; 🇺🇸 Cleveland, Ohio, United States

Penn State University Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

University Gastroenterology; 🇺🇸 Providence, Rhode Island, United States

MUSC Department of Gastroenterology; 🇺🇸 Charleston, South Carolina, United States

Gastroenterology Associates, PA; 🇺🇸 Greenville, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Amel Med LLC; 🇺🇸 Austin, Texas, United States

Advanced Gastroenterology Associates, PA.; 🇺🇸 Decatur, Texas, United States

Biopharma Informatic, LLC; 🇺🇸 Katy, Texas, United States

GI Alliance - Webster; 🇺🇸 Webster, Texas, United States

Clinical Research Partners, LLC; 🇺🇸 Richmond, Virginia, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Bankstown-Lidcombe Hospital; 🇦🇺 Bankstown, New South Wales, Australia

Emeritus Research, Sydney; 🇦🇺 Botany, New South Wales, Australia

Northern Beaches Clinical Research; 🇦🇺 Brookvale, New South Wales, Australia

St Vincent's Hospital Melbourne; 🇦🇺 Darlinghurst, New South Wales, Australia

Sutherland Shire Clinical Research; 🇦🇺 Miranda, New South Wales, Australia

AusTrials St Leonards; 🇦🇺 St Leonards, New South Wales, Australia

Wollongong Clinical Research; 🇦🇺 Wollongong, New South Wales, Australia

Griffith University Clinical Trial Unit; 🇦🇺 Gold Coast, Queensland, Australia

Coastal Digestive Health; 🇦🇺 Maroochydore, Queensland, Australia

Mater Hospital Brisbane; 🇦🇺 South Brisbane, Queensland, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Emeritus Research, Melbourne; 🇦🇺 Camberwell, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

AusTrials Sunshine; 🇦🇺 St Albans, Victoria, Australia

Gastroenterology and Internal Medicine Research Institute (GIRI); 🇨🇦 Edmonton, Alberta, Canada

South Edmonton Gastroenterology; 🇨🇦 Edmonton, Alberta, Canada

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

PerCuro Clinical Research Ltd.; 🇨🇦 Victoria, British Columbia, Canada

St. Boniface Hospital Inc.; 🇨🇦 Winnipeg, Manitoba, Canada

Health Sciences Centre Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Scope Clinic; 🇨🇦 Brampton, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Centricity Research London Victoria; 🇨🇦 London, Ontario, Canada

Centricity Research Ottawa Greenbelt; 🇨🇦 Nepean, Ontario, Canada

Scott Shulman Medicine Professional Corporation; 🇨🇦 North Bay, Ontario, Canada

The Ottawa Hospital - Riverside Campus; 🇨🇦 Ottawa, Ontario, Canada

The Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Viable Clinical Research; 🇨🇦 Sudbury, Ontario, Canada

Kensington Screening Clinic; 🇨🇦 Toronto, Ontario, Canada

CHUM Centre de Recherche; 🇨🇦 Montreal, Quebec, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Southern Clinical Trials Totara; 🇳🇿 Auckland, New Zealand

Optimal Clinical Trials - North; 🇳🇿 Auckland, New Zealand

Optimal Clinical Trials - Central; 🇳🇿 Auckland, New Zealand

P3 Research Limited (Hawkes Bay); 🇳🇿 Havelock North, New Zealand

Capital, Coast and Hutt Valley District Hutt Hospital; 🇳🇿 Lower Hutt, New Zealand

P3 Research Limited (Palmerston North); 🇳🇿 Palmerston North, New Zealand

Lakeland Clinical Trials Wellington; 🇳🇿 Wellington, New Zealand

P3 Research Limited (Wellington); 🇳🇿 Wellington, New Zealand