NCT07483073

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis, Ulcerative
• Crohn Disease

Interventions

Type	Name	Description
DRUG	Mirikizumab - Intravenous (IV)	Administered IV
DRUG	Mirikizumab - Subcutaneous (SC)	Administered SC
DRUG	LY4395089	Administered orally

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2028-03-01
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

72 sites across 10 countries: United States, Belgium, Brazil, Canada, China, Germany, Hungary, Israel, Italy, Poland

Regulatory

• FDA-regulated drug study