A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
- Registration Number
- NCT05499130
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.
Secondary objectives:
* To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures
* To evaluate the safety and tolerability of the 2 different dose regimens
* To evaluate the immunogenicity of the 2 different dose regimens
The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
- The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
- The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
- Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
- Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer
NOTE- Additional criteria apply, please contact the investigator for more information
- The participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician
- Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
- Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
- Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
- Participant anticipates requiring major surgery during this study.
- A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
- A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
- A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
- A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
- The participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
- Presence of a transplanted organ
- A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
- Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
- Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent
NOTE- Additional criteria apply, please contact the investigator for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TEV-48574 Dose A (UC) TEV-48574 Dose regimen A administered by subcutaneous infusion for participants with UC TEV-48574 Dose B (UC) TEV-48574 Dose regimen B administered by Subcutaneous infusion for participants with UC TEV-48574 Dose A (CD) TEV-48574 Dose regimen A administered by subcutaneous infusion for participants with CD TEV-48574 Dose B (CD) TEV-48574 Dose regimen B administered by subcutaneous infusion for participants with CD Placebo UC Placebo Matching Placebo Placebo CD Placebo Matching Placebo
- Primary Outcome Measures
Name Time Method Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score Week 14 Clinical remission is a modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by:
* stool frequency subscore of 0 or 1,
* rectal bleeding subscore of 0, and
* endoscopic subscore of 0 or 1, where a score of 1 does not include "friability" Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity) and the total score from 0 to 9, respectivelyNumber of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease Week 14 Endoscopic response defined as a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline
- Secondary Outcome Measures
Name Time Method Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score Week 14 Endoscopic remission defined as a Mayo endoscopic subscore of 0
Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score Baseline and Week 14 Clinical response at week 14, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index (CDAI) Baseline, Weeks 4, 8, 12 and 14 Clinical response defined as a ≥100-point decrease in CDAI score
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score Week 14 Clinical remission defined as a CDAI score less than 150
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score Baseline and Week 14 Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency)
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score Week 14 Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale
Number of Participants Who Experience Adverse Events Baseline up to Week 18 Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score Week 14 Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1
Number of participants with moderate to severe UC with a clinical response as defined as a decrease from baseline in 2-item patient-reported outcome (PRO2) Baseline and Week 14 Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) Baseline and Week 14 Endoscopic response defined as a decrease from baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of \>50%. The MM-SES-CD takes into account the chances of each parameter (presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures) achieving endoscopic remission.
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events Up to Week 18 Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score Week 14 Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA) Baseline, Weeks 2, 4, 8, 14, and 18 Number of ADA positive participants with the presence of neutralizing ADA Weeks 2, 4, 8, 14, and 18
Trial Locations
- Locations (164)
Teva Investigational Site 15568
🇺🇸Sun City, Arizona, United States
Teva Investigational Site 15556
🇺🇸San Diego, California, United States
Teva Investigational Site 15747
🇺🇸San Diego, California, United States
Teva Investigational Site 15357
🇺🇸Kissimmee, Florida, United States
Teva Investigational Site 15563
🇺🇸Miami, Florida, United States
Teva Investigational Site 15365
🇺🇸Miami, Florida, United States
Teva Investigational Site 15748
🇺🇸Miami, Florida, United States
Teva Investigational Site 15375
🇺🇸Orlando, Florida, United States
Teva Investigational Site 15359
🇺🇸Pinellas Park, Florida, United States
Teva Investigational Site 15566
🇺🇸Glenview, Illinois, United States
Scroll for more (154 remaining)Teva Investigational Site 15568🇺🇸Sun City, Arizona, United States