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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 143
- Locations
- 403
- Primary Endpoint
- Percentage of Participants Achieving Clinical Remission
Study Overview
Brief 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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
- •Have experienced a thrombotic event within 24 weeks before baseline.
- •Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
- •Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
- •Have a history of certain adenomas, dysplasia's, or malignancies.
Arms & Interventions
Eltrekibart + Placebo
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Intervention: Placebo (Drug)
Mirikizumab + Placebo
Participants will receive mirikizumab and placebo or mirikizumab.
Intervention: Placebo (Drug)
Placebo
Participants will receive placebo or mirikizumab.
Intervention: Placebo (Drug)
Placebo
Participants will receive placebo or mirikizumab.
Intervention: Mirikizumab (Drug)
Eltrekibart + Placebo
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Intervention: Eltrekibart (Drug)
Eltrekibart + Placebo
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Intervention: Mirikizumab (Drug)
Eltrekibart + Mirikizumab
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Intervention: Mirikizumab (Drug)
Mirikizumab + Placebo
Participants will receive mirikizumab and placebo or mirikizumab.
Intervention: Mirikizumab (Drug)
Eltrekibart + Mirikizumab
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Intervention: Eltrekibart (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Achieving Clinical Remission
Time Frame: Week 12
Percentage of Participants Achieving Clinical Remission
Secondary Outcomes
- Percentage of Participants Achieving Clinical Response(Week 12)
- Percentage of Participants Achieving Endoscopic Improvement(Week 12)
- PK: Ctrough ss of Mirikizumab(Week 12)
- Percentage of Participants Achieving Endoscopic Remission(Week 12)
- Percentage of Participants Achieving Clinical Remission(Week 52)
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement(Week 12)
- Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score(Baseline, Week 12)
- Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart(Week 12)