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

Lilly

Status and phase

Enrolling

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: Mirikizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519945

2023-507657-15-00 (Other Identifier)

2017 004092 31 (EudraCT Number)

16596

I6T-MC-AMAP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,063 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and 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.