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NCT04469062 Clinical Trial

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— LUCENT-ACT  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04469062
Other study ID # 16825
Secondary ID I6T-MC-AMBI2019-
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date April 20, 2021
Est. completion date June 5, 2024

Study information
Verified date May 2021
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 5, 2024
Est. primary completion date March 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mirikizumab IV
Administered IV
• Mirikizumab SC
Administered SC
• Vedolizumab IV
Administered IV
• Placebo IV
Administered IV
• Placebo SC
Administered SC

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants in Histologic Remission Histologic remission based on histology. Week 12
Secondary Percentage of Participants in Symptomatic Remission Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores. Week 52
Secondary Percentage of Participants in Clinical Remission Clinical remission based on MMS. Week 52
Secondary Percentage of Participants in Endoscopic Remission Endoscopic remission based on MMS ES. Week 52
Secondary Percentage of Participants with Clinical Response Clinical response based on MMS. Week 12
Secondary Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline) CS free remission without surgery based on clinical remission, symptomatic remission and no CS use. Week 52
Secondary Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline Percentage of participants with resolution of EIMs among those that had them at baseline. Week 52
Secondary Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score Change from baseline on the IBDQ score. Baseline, Week 52
Secondary Percentage of Participants Undergoing Surgery for UC (Including Colectomy) Percentage of participants undergoing surgery for UC (including colectomy). Week 52
Secondary Percentage of Participants Hospitalized for UC Percentage of participants hospitalized for UC. Week 52
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