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

Phase 3

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Drug: Mirikizumab IV; Drug: Vedolizumab IV; Drug: Placebo IV; Drug: Placebo SC; Drug: Mirikizumab SC

• Registration Number: NCT04469062
• Lead Sponsor: Eli Lilly and Company

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Start: 2021-04-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-06
• Primary Completion: 2024-03-13
• Study Completion: 2024-06-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo SC	Placebo administered SC and IV.
Mirikizumab	Mirikizumab IV	Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Mirikizumab	Mirikizumab SC	Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Vedolizumab	Vedolizumab IV	Vedolizumab administered IV.
Placebo	Placebo IV	Placebo administered SC and IV.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in Histologic Remission	Week 12	Histologic remission based on histology.

Secondary Outcome Measures

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