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Study of Mirikizumab and LY4395089 for Ulcerative Colitis or Crohn's Disease

This study, called IIBD, is looking at new treatments for adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). You could receive Mirikizumab, given either through a vein (intravenous) or as a shot under the skin (subcutaneous), or LY4395089, taken by mouth. To join, you must be between 18 and 80 years old and have a confirmed diagnosis of UC or CD for at least three months. For UC, you need to have moderately to severely active disease based on a specific scoring system. The main goal of this study is to see how many participants are assigned to each treatment group. The study's current status is unclear.

Study design
This is an interventional master protocol study that will include individual sub-studies. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline and up to Day 42. The studies will last at least 62 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07483073

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Eli Lilly and Company
~60 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Mirikizumab - Intravenous (IV)Mirikizumab - Subcutaneous (SC)LY4395089

At a glance

Recruiting sites
28 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Measured over Baseline, Up to Day 42

Conditions

Colitis, Ulcerative
Crohn Disease

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

70 sites across 20 states
Poland10
Brazil9
China9
Israel7
Italy6
Germany5
Belgium4
Canada3

Study leadership

  • Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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