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

In plain English

What this trial is testing

This study is testing Mirikizumab - Intravenous (IV) (a drug), Mirikizumab - Subcutaneous (SC) (a drug) and LY4395089 (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative and Crohn Disease.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 80
• Any sex

Some of the main requirements, copied from the record:

• 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…
• 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…
• 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…
• 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

Plus 1 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 60 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-05-04.
• Main results expected around 2027-06 (estimate from the record).
• 70 study sites listed (44 marked recruiting) in Belgium, Brazil, Canada, China and Germany and 5 more countries.

Groups in this study

• Mirikizumab (listed as: active comparator group)
• LY4395089 and Mirikizumab Co-Administration (listed as: experimental group)

Main thing being measured

• Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) (Baseline, Up to Day 42)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.