A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company
Summary
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC * Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader and RB ≥1, with endoscopy performed within 21 days before baseline * Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, d…
Interventions
- DrugLY4268989
Administered PO
- DrugMirikizumab
Administered IV then SC
- DrugLY4268989 Placebo
Administered PO
Locations (149)
- Mayo Clinic in Arizona - ScottsdaleScottsdale, Arizona
- Clinnova Research - AnaheimAnaheim, California
- Om Research LLCLancaster, California
- Biopharma Informatic, LLCLos Angeles, California
- Peak Gastroenterology AssociatesColorado Springs, Colorado
- NeoClinical ResearchHialeah, Florida