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
Eli Lilly and Company
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 ac…
Interventions
- DrugMirikizumab - Intravenous (IV)
Administered IV
- DrugMirikizumab - Subcutaneous (SC)
Administered SC
- DrugLY4395089
Administered orally
Locations (72)
- Biopharma Informatic, LLCLos Angeles, California
- Om Research LLCOxnard, California
- South Denver GastroenterologyEnglewood, Colorado
- Gastro Health Research - MiamiMiami, Florida
- Ezy Medical ResearchMiami Lakes, Florida
- Atlanta Gastroenterology Associates - Peachtree DunwoodyAtlanta, Georgia