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

May 4, 2021 updated by: Eli Lilly and Company

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Histologic Remission
Time Frame: Week 12
Histologic remission based on histology.
Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2021

Primary Completion (Anticipated)

March 13, 2024

Study Completion (Anticipated)

June 5, 2024

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16825
  • I6T-MC-AMBI (Other Identifier: Eli Lilly and Company)
  • 2019-001653-99 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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