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 : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Mirikizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||840 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Mirikizumab administered subcutaneously (SC).
Other Name: LY3074828
- Percentage of Participants in Clinical Remission [ Time Frame: Week 52 ]Clinical remission based on the modified Mayo Score (MMS).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519945
|Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or||1-317-615-4559||ClinicalTrials.email@example.com|
Show 378 Study Locations
|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|