Clinical trial NCT04469062: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Interleukin-23 (IL-23) antibody
IL-23p19
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants in Histologic Remission
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants in Symptomatic Remission
timeFrame: Week 52
measure: Percentage of Participants in Clinical Remission
timeFrame: Week 52
measure: Percentage of Participants in Endoscopic Remission
timeFrame: Week 52
measure: Percentage of Participants with Clinical Response
timeFrame: Week 12
measure: Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
timeFrame: Week 52
measure: Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
timeFrame: Week 52
measure: Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: Baseline, Week 52
measure: Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
timeFrame: Week 52
measure: Percentage of Participants Hospitalized for UC
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: