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NCT Number: NCT07483073

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

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.

Recruiting

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AZ Maria Middelares, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirikizumab - Intravenous (IV)

Drug

Administered IV

Other names: LY3074828

Mirikizumab - Subcutaneous (SC)

Drug

Administered SC

Other names: LY3074828

LY4395089

Drug

Administered orally

Primary outcomes

  1. Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)

    Time frame: Baseline, Up to Day 42

Study contacts

Contact information is provided by the study sponsor or research team.

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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