LUCENT-ACT: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04469062

Collaborator

(none)

Enrollment

Arms

37.5

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Mirikizumab IV Drug: Mirikizumab SC Drug: Vedolizumab IV Drug: Placebo IV Drug: Placebo SC	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 20, 2021

Anticipated Primary Completion Date :

Mar 13, 2024

Anticipated Study Completion Date :

Jun 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mirikizumab Mirikizumab administered intravenously (IV) and subcutaneously (SC).	Drug: Mirikizumab IV Administered IV Other Names: LY3074828 Drug: Mirikizumab SC Administered SC Other Names: LY3074828
Active Comparator: Vedolizumab Vedolizumab administered IV.	Drug: Vedolizumab IV Administered IV
Placebo Comparator: Placebo Placebo administered SC and IV.	Drug: Placebo IV Administered IV Drug: Placebo SC Administered SC

Arm

Intervention/Treatment

Experimental: Mirikizumab

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

Drug: Mirikizumab IV

Administered IV

Other Names:

LY3074828

Drug: Mirikizumab SC

Administered SC

Other Names:

LY3074828

Active Comparator: Vedolizumab

Vedolizumab administered IV.

Drug: Vedolizumab IV

Administered IV

Placebo Comparator: Placebo

Placebo administered SC and IV.

Drug: Placebo IV

Administered IV

Drug: Placebo SC

Administered SC

Outcome Measures

Primary Outcome Measures

Percentage of Participants in Histologic Remission [Week 12]
Histologic remission based on histology.

Secondary Outcome Measures

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 in Clinical Remission [Week 52]
Clinical remission based on MMS.
Percentage of Participants in Endoscopic Remission [Week 52]
Endoscopic remission based on MMS ES.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company