NCT04469062WithdrawnPhase 3
A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Eli Lilly and Company
- Primary Endpoint
- Percentage of Participants in Histologic Remission
Study Overview
Brief Summary
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must have a diagnosis of UC for at least 3 months prior to baseline
- •Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
- •Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
- •Participants must, if female, meet the contraception requirements
Exclusion Criteria
- •Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
- •Participants must not have had a previous colectomy
- •Participants must not have current evidence of toxic megacolon
- •Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
- •Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Arms & Interventions
Mirikizumab
Experimental
Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Intervention: Mirikizumab IV (Drug)
Mirikizumab
Experimental
Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Intervention: Mirikizumab SC (Drug)
Vedolizumab
Active Comparator
Vedolizumab administered IV.
Intervention: Vedolizumab IV (Drug)
Placebo
Placebo Comparator
Placebo administered SC and IV.
Intervention: Placebo IV (Drug)
Placebo
Placebo Comparator
Placebo administered SC and IV.
Intervention: Placebo SC (Drug)
Outcomes
Primary Outcomes
Percentage of Participants in Histologic Remission
Time Frame: Week 12
Histologic remission based on histology.
Secondary Outcomes
- Percentage of Participants in Symptomatic Remission(Week 52)
- Percentage of Participants with Clinical Response(Week 12)
- Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)(Week 52)
- Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline(Week 52)
- Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score(Baseline, Week 52)
- Percentage of Participants Undergoing Surgery for UC (Including Colectomy)(Week 52)
- Percentage of Participants Hospitalized for UC(Week 52)
- Percentage of Participants in Clinical Remission(Week 52)
- Percentage of Participants in Endoscopic Remission(Week 52)
Investigators
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