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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT03519945
• Date of registration: 07/05/2018
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
• Scientific 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
• Date of first enrolment: July 18, 2018
• Target sample size: 1063
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03519945
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, China, 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

Contacts

• Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

- Inclusion Criteria

- Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Mirikizumab

Primary Outcome(s)

Percentage of Participants in Clinical Remission [Time Frame: Week 52]

Secondary Outcome(s)

Percentage of Participants Who Undergo UC Surgeries Including Colectomy [Time Frame: Baseline to Week 160]

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

Percentage of Participants in Corticosteroid-free Remission [Time Frame: Week 52]

Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52 [Time Frame: Week 52]

Percentage of Participants in Endoscopic Remission [Time Frame: Week 52]

Percentage of Participants Who are Hospitalized Due to UC [Time Frame: Baseline to Week 160]

UC Symptoms: Numeric Rating Score [Time Frame: Week 160]

Secondary ID(s)

2023-507657-15-00

16596

2017 004092 31

I6T-MC-AMAP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors