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Phase 2Recruiting

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

Sponsored by Eli Lilly and Company

About this study

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.

Where this study is enrolling (9)

  • Biopharma Informatic, LLC

    Los Angeles, California

    Call 281-944-3610

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  • Om Research LLC

    Oxnard, California

    Call 661-388-2239

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  • Ezy Medical Research

    Miami Lakes, Florida

    Call 786-483-8162

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  • Atlanta Gastroenterology Associates - Peachtree Dunwoody

    Atlanta, Georgia

    I'm interested

  • Rush University Medical Center

    Chicago, Illinois

    I'm interested
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  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas

    Call 785-368-0477

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  • KAD Clinical Research

    St Louis, Missouri

    Call 314-254-3168

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  • Vector Clinical Trials

    Las Vegas, Nevada

    Call 702-750-0000

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  • Southern Star Research Institute

    San Antonio, Texas

    Call 210-581-2812

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.