NCT07483073 A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
| NCT ID | NCT07483073 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Eli Lilly and Company |
| Condition | Colitis, Ulcerative |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-05-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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, 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
Contact & Investigator
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
✉ clinical_inquiry_hub@lilly.com📞 1-317-615-4559
Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT07483073 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Colitis, Ulcerative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07483073 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07483073 currently recruiting?
Yes, NCT07483073 is actively recruiting participants. Contact the research team at clinical_inquiry_hub@lilly.com for enrollment information.
Where is the NCT07483073 trial being conducted?
This trial is being conducted at Scottsdale, United States, Los Angeles, United States, Oxnard, United States, Englewood, United States and 11 additional locations.
Who is sponsoring the NCT07483073 clinical trial?
NCT07483073 is sponsored by Eli Lilly and Company. The principal investigator is Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or at Eli Lilly and Company. The trial plans to enroll 60 participants.