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A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

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ClinicalTrials.gov Identifier: NCT03519945
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mirikizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : August 23, 2023
Estimated Study Completion Date : August 23, 2023

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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]
    Clinical remission based on the modified Mayo Score (MMS).


Secondary Outcome Measures :
  1. Percentage of Participants in Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on the MMS Endoscopic Subscores (ES).

  2. Percentage of Participants in Corticosteroid-free Remission [ Time Frame: Week 52 ]
    Percentage of participants in corticosteroid-free remission.

  3. Percentage of Participants with Mucosal Healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing based on a histologic disease activity index.

  4. Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Baseline to Week 52 ]
    Health Related Quality of Life based on IBDQ score.

  5. UC Symptoms: Numeric Rating Score [ Time Frame: Week 160 ]
    UC symptoms based on numeric rating score.

  6. Percentage of Participants Who are Hospitalized Due to UC [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who are hospitalized due to UC.

  7. Percentage of Participants Who Undergo UC Surgeries Including Colectomy [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who undergo UC surgeries including colectomy.


Eligibility Criteria
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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 from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) who have had at least one study drug administration and have not had early termination of study drug.
    • Female participants must agree to contraception requirements.

  • Exclusion Criteria

    • Participants must not have developed a new condition, including cancer in the originator study.
    • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
    • Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
    • Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Contacts and Locations
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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): NCT03519945


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

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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03519945     History of Changes
Other Study ID Numbers: 16596
I6T- MC-AMAP ( Other Identifier: Eli Lilly and Company )
2017 004092 31 ( EudraCT Number )
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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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:
Inflammatory Bowel Disease

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases