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

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mirikizumab IV
Mirikizumab SC
Vedolizumab IV
Placebo IV
Placebo SC
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Interleukin-23 (IL-23) antibody, IL-23p19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Mirikizumab

    Vedolizumab

    Placebo

    Arm Description

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

    Vedolizumab administered IV.

    Placebo administered SC and IV.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants in Histologic Remission
    Histologic remission based on histology.

    Secondary Outcome Measures

    Percentage of Participants in Symptomatic Remission
    Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
    Percentage of Participants in Clinical Remission
    Clinical remission based on MMS.
    Percentage of Participants in Endoscopic Remission
    Endoscopic remission based on MMS ES.
    Percentage of Participants with Clinical Response
    Clinical response based on MMS.
    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.
    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.
    Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    Change from baseline on the IBDQ score.
    Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
    Percentage of participants undergoing surgery for UC (including colectomy).
    Percentage of Participants Hospitalized for UC
    Percentage of participants hospitalized for UC.

    Full Information

    First Posted
    July 10, 2020
    Last Updated
    May 4, 2021
    Sponsor
    Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04469062
    Brief Title
    A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
    Study Start Date
    April 20, 2021 (Anticipated)
    Primary Completion Date
    March 13, 2024 (Anticipated)
    Study Completion Date
    June 5, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eli Lilly and Company

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis
    Keywords
    Interleukin-23 (IL-23) antibody, IL-23p19

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mirikizumab
    Arm Type
    Experimental
    Arm Description
    Mirikizumab administered intravenously (IV) and subcutaneously (SC).
    Arm Title
    Vedolizumab
    Arm Type
    Active Comparator
    Arm Description
    Vedolizumab administered IV.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo administered SC and IV.
    Intervention Type
    Drug
    Intervention Name(s)
    Mirikizumab IV
    Other Intervention Name(s)
    LY3074828
    Intervention Description
    Administered IV
    Intervention Type
    Drug
    Intervention Name(s)
    Mirikizumab SC
    Other Intervention Name(s)
    LY3074828
    Intervention Description
    Administered SC
    Intervention Type
    Drug
    Intervention Name(s)
    Vedolizumab IV
    Intervention Description
    Administered IV
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo IV
    Intervention Description
    Administered IV
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo SC
    Intervention Description
    Administered SC
    Primary Outcome Measure Information:
    Title
    Percentage of Participants in Histologic Remission
    Description
    Histologic remission based on histology.
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants in Symptomatic Remission
    Description
    Symptomatic remission based on modified Mayo Score (MMS) stool frequency (SF) and rectal bleeding (RB) subscores.
    Time Frame
    Week 52
    Title
    Percentage of Participants in Clinical Remission
    Description
    Clinical remission based on MMS.
    Time Frame
    Week 52
    Title
    Percentage of Participants in Endoscopic Remission
    Description
    Endoscopic remission based on MMS ES.
    Time Frame
    Week 52
    Title
    Percentage of Participants with Clinical Response
    Description
    Clinical response based on MMS.
    Time Frame
    Week 12
    Title
    Percentage of Participants with Corticosteroid (CS) Free Remission without Surgery (Subgroup of Participants on CS at Baseline)
    Description
    CS free remission without surgery based on clinical remission, symptomatic remission and no CS use.
    Time Frame
    Week 52
    Title
    Percentage of Participants with Resolution of Extraintestinal Manifestations (EIMs) Among Those That had Them at Baseline
    Description
    Percentage of participants with resolution of EIMs among those that had them at baseline.
    Time Frame
    Week 52
    Title
    Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score
    Description
    Change from baseline on the IBDQ score.
    Time Frame
    Baseline, Week 52
    Title
    Percentage of Participants Undergoing Surgery for UC (Including Colectomy)
    Description
    Percentage of participants undergoing surgery for UC (including colectomy).
    Time Frame
    Week 52
    Title
    Percentage of Participants Hospitalized for UC
    Description
    Percentage of participants hospitalized for UC.
    Time Frame
    Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    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)
    Organizational Affiliation
    Eli Lilly and Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 URL
    https://vivli.org/
    Links:
    URL
    https://trials.lillytrialguide.com/en-US/trial/2CU7GWC1qkMxLL0Qo3HP8a
    Description
    A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)

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

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