Testing Several Drugs for Ulcerative Colitis or Crohn's Disease in Adults
Tests new drugs in adults with moderate to severe ulcerative colitis or Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Key facts
- Where
- Gent, Leuven, and Roeselare, BelgiumSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07483073, who can take part
Where in Belgium
- Az Maria Middelares GentGent, BelgiumTaking people
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT07483073EU 2025-524112-11-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
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; 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: Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol; 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; 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 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.