A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Eli Lilly and Company · NCT07483073
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 60
- US sites recruiting
- 12
- Study start
- May 4, 2026
- Record last updated
- October 22, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Mirikizumab - Intravenous (IV); Mirikizumab - Subcutaneous (SC); LY4395089
Conditions: Colitis, Ulcerative; Crohn Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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.
- 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
Recruiting US locations
Biopharma Informatic, LLC
Los Angeles, CA 90035
Site contact: (281) 944-3610
Om Research LLC
Oxnard, CA 93030
Site contact: 661.388.2239
South Denver Gastroenterology
Englewood, CO 80113
Site contact: Marcelo Kugelmas
Gastro Health Research - Miami
Miami, FL 33176
Site contact: Lukasz Kwapisz
Ezy Medical Research
Miami Lakes, FL 33015
Site contact: 7864838162
Atlanta Gastroenterology Associates - Peachtree Dunwoody
Atlanta, GA 30342
Site contact: Nitin Gupta
Cotton O'Neil Digestive Health Center
Topeka, KS 66606
Site contact: 785-368-0477
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Wyoming, MI 49519
Site contact: Allan Coates
KAD Clinical Research
St Louis, MO 63123
Site contact: 1-314-254-3168
Vector Clinical Trials
Las Vegas, NV 89128
Site contact: 7027500000
One of a Kind Clinical Research Center - Kingwood
Kingwood, TX 77339
Site contact: Sushovan Guha
Southern Star Research Institute
San Antonio, TX 78229
Site contact: 210-581-2812
Study contacts (from the official record)
- There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · clinical_inquiry_hub@lilly.com