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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469062
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
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).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 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
Estimated Study Start Date : April 20, 2021
Estimated Primary Completion Date : March 13, 2024
Estimated Study Completion Date : June 5, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Arm Intervention/treatment
Experimental: Mirikizumab
Mirikizumab administered intravenously (IV) and subcutaneously (SC).
Drug: Mirikizumab IV
Administered IV
Other Name: LY3074828

Drug: Mirikizumab SC
Administered SC
Other Name: 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




Primary Outcome Measures :
  1. Percentage of Participants in Histologic Remission [ Time Frame: Week 12 ]
    Histologic remission based on histology.


Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission based on MMS.

  3. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on MMS ES.

  4. Percentage of Participants with Clinical Response [ Time Frame: Week 12 ]
    Clinical response based on MMS.

  5. 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.

  6. 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.

  7. Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline, Week 52 ]
    Change from baseline on the IBDQ score.

  8. Percentage of Participants Undergoing Surgery for UC (Including Colectomy) [ Time Frame: Week 52 ]
    Percentage of participants undergoing surgery for UC (including colectomy).

  9. Percentage of Participants Hospitalized for UC [ Time Frame: Week 52 ]
    Percentage of participants hospitalized for UC.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04469062


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04469062    
Other Study ID Numbers: 16825
I6T-MC-AMBI ( Other Identifier: Eli Lilly and Company )
2019-001653-99 ( EudraCT Number )
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 15, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Interleukin-23 (IL-23) antibody
IL-23p19
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vedolizumab
Gastrointestinal Agents