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 3, 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.
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
|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 330 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|