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RecruitingPhase 2

A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease

A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well new treatments work and how safe they are for adults with moderate to severe ulcerative colitis or Crohn’s disease. Both diseases cause swelling and damage in the bowel. Participants will join a smaller study within this study, which will last at least 62 weeks.

Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have had ulcerative colitis or Crohn’s disease for at least 3 months, confirmed by symptoms, a bowel exam with a camera, and a tissue sample report.
  • For ulcerative colitis, you must have moderate to severe active disease, with rectal bleeding and study-required scores on a recent bowel camera exam.
  • For Crohn’s disease, you must have moderate to severe active disease, with study-required scores for symptoms and a recent bowel camera exam.
  • At least one past treatment must not have worked well enough, stopped working, or caused side effects you could not tolerate. These include steroids, drugs that change the immune system, or advanced treatments.
  • Your screening lab test results must meet the study’s limits.

Who can't join

  • You cannot have bowel inflammation that is not clearly diagnosed as ulcerative colitis or Crohn’s disease, or primary sclerosing cholangitis, a disease that scars the bile ducts.
  • You cannot join the ulcerative colitis study if you currently have Crohn’s disease, or the Crohn’s disease study if you currently have ulcerative colitis.
  • You cannot have had or need certain surgeries to remove bowel or operate on the intestines or inside the belly, as defined by the study.
  • You cannot have certain bowel problems, such as narrowing or short bowel syndrome, when too little bowel remains. Some narrowing is allowed for Crohn’s disease.
  • You cannot have a serious illness that is not controlled if the study doctor thinks it could make participation unsafe or affect the results.
  • You cannot have had more than 5 approved advanced treatments that work in different ways fail to help your bowel disease.
  • You cannot have had a treatment called an anti-IL-23p19 antibody fail to help.
  • You cannot have taken or need medicines for your bowel disease that the study does not allow.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD. * For UC: * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2. * For CD: * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization * Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD * Have screening laboratory test results within the protocol specified parameters. Exclusion Criteria: * Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis * For UC - must not have a current diagnosis of CD * For CD - must not have a current diagnosis of UC * Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol * Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome * Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data * Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action * Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment * Must not have received or will need any prohibited medications for UC or CD as specified in the protocol

Study sites (14)

AZ

CA

CO

FL

GA

  • Atlanta Gastroenterology Associates - Peachtree Dunwoody · Atlanta, GA 30342Nitin Gupta · Principal investigatorMore trials in Atlanta

IL

  • Rush University Medical Center · Chicago, IL 60612Atsushi Sakuraba · Principal investigatorMore trials in Chicago

KS

MI

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center · Wyoming, MI 49519Allan Coates · Principal investigatorMore trials in Wyoming

MO

NV

TX