A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
- Registration Number
- NCT03519945
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1063
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mirikizumab Mirikizumab Mirikizumab administered subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percentage of Participants in Clinical Remission Week 52 Clinical remission based on the modified Mayo Score (MMS).
- Secondary Outcome Measures
Name Time Method Percentage of Participants in Endoscopic Remission Week 52 Endoscopic remission based on the MMS Endoscopic Subscore (ES).
Percentage of Participants in Corticosteroid-free Remission Week 52 Participants in corticosteroid-free remission.
Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score Baseline to Week 52 Health Related Quality of Life based on IBDQ score.
Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52 Week 52 Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.
UC Symptoms: Numeric Rating Score Week 160 UC symptoms based on numeric rating score.
Percentage of Participants Who are Hospitalized Due to UC Baseline to Week 160 Participants who are hospitalized due to UC.
Percentage of Participants Who Undergo UC Surgeries Including Colectomy Baseline to Week 160 Participants who undergo UC surgeries including colectomy.
Trial Locations
- Locations (359)
Digestive Health Specialists
🇺🇸Dothan, Alabama, United States
Research Solutions of Arizona
🇺🇸Litchfield Park, Arizona, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
InSite Digestive Health Care
🇺🇸Arcadia, California, United States
Care Access - Berkeley
🇺🇸Berkeley, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Om Research LLC
🇺🇸Lancaster, California, United States
California Medical Research Associates
🇺🇸Northridge, California, United States
Inland Empire Clinical Trials, LLC
🇺🇸Rialto, California, United States
Clinical Applications Laboratories, Inc.
🇺🇸San Diego, California, United States
Scroll for more (349 remaining)Digestive Health Specialists🇺🇸Dothan, Alabama, United States