An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company
Summary
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
Description
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have had an established diagnosis of UC of ≥3 months in duration before baseline. * Have moderately to severely active UC as assessed by the UC disease activity score. * Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). * Are on a stable dose of certain oral UC medications (including corticosteroids). * Must meet contraception requirements. Exclusion Criteria…
Interventions
- DrugEltrekibart
Administered
- DrugMirikizumab
Administered
- DrugPlacebo
Administered
Locations (207)
- AZ Gastro Care - ChandlerChandler, Arizona
- Applied Research Center of ArkansasLittle Rock, Arkansas
- Preferred Research PartnersLittle Rock, Arkansas
- Erick Alayo Medical Corp/Gastro SB ClinicChula Vista, California
- Southern California GI and Liver Centers (SCLC)Coronado, California
- Valley View ResearchGarden Grove, California