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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 : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 7, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE July 18, 2018
Estimated Primary Completion Date August 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]
Clinical remission based on the modified Mayo Score (MMS).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03519945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Percentage of Participants in Endoscopic Remission [ Time Frame: Week 52 ]
    Endoscopic remission based on the MMS Endoscopic Subscores (ES).
  • Percentage of Participants in Corticosteroid-free Remission [ Time Frame: Week 52 ]
    Percentage of participants in corticosteroid-free remission.
  • Percentage of Participants with Mucosal Healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing based on a histologic disease activity index.
  • 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.
  • UC Symptoms: Numeric Rating Score [ Time Frame: Week 160 ]
    UC symptoms based on numeric rating score.
  • Percentage of Participants Who are Hospitalized Due to UC [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who are hospitalized due to UC.
  • Percentage of Participants Who Undergo UC Surgeries Including Colectomy [ Time Frame: Baseline to Week 160 ]
    Percentage of participants who undergo UC surgeries including colectomy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Mirikizumab
Administered SC.
Other Name: LY3074828
Study Arms  ICMJE Experimental: Mirikizumab
Mirikizumab administered subcutaneously (SC).
Intervention: Drug: Mirikizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
840
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 23, 2023
Estimated Primary Completion Date August 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Croatia,   Czechia,   Denmark,   France,   Georgia,   Germany,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Moldova, Republic of,   Netherlands,   Poland,   Romania,   Russian Federation,   Saudi Arabia,   Serbia,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03519945
Other Study ID Numbers  ICMJE 16596
I6T- MC-AMAP ( Other Identifier: Eli Lilly and Company )
2017 004092 31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date July 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP