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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2024-06-05

Brief Summary

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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).

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mirikizumab

Mirikizumab administered intravenously (IV) and subcutaneously (SC).

Group Type EXPERIMENTAL

Mirikizumab IV

Intervention Type DRUG

Administered IV

Mirikizumab SC

Intervention Type DRUG

Administered SC

Vedolizumab

Vedolizumab administered IV.

Group Type ACTIVE_COMPARATOR

Vedolizumab IV

Intervention Type DRUG

Administered IV

Placebo

Placebo administered SC and IV.

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type DRUG

Administered IV

Placebo SC

Intervention Type DRUG

Administered SC

Interventions

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Mirikizumab IV

Administered IV

Intervention Type DRUG

Mirikizumab SC

Administered SC

Intervention Type DRUG

Vedolizumab IV

Administered IV

Intervention Type DRUG

Placebo IV

Administered IV

Intervention Type DRUG

Placebo SC

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3074828 LY3074828

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No