A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

Key facts

Study ID

NCT03524092

Run by

Eli Lilly and Company

People needed

1328

Starts

2018-10-19

Expected to finish

2025-02-17

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
• Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
• If female, must meet the contraception requirements.

You may not qualify if…

• Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
• Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
• Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
• Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
• Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
• Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.

Where it is running

• The First Hospital Affiliated to AMU (Southwest Hospital) — Chongqing, Chongqing Municipality, China
• The Sixth Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China
• The Affiliated Drum Tower Hospital of Nanjing University — Nanjing, Jiangsu, China
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China
• Nanjing Medical University - Nanjing Jiangning Hospital — Nanjing, Jiangsu, China
• Jiangxi Pingxiang People's Hospital — Pingxiang, Jiangxi, China
• Jilin Central General Hospital — Jilin City, Jilin, China
• Qilu Hospital of Shandong University — Jinan, Shandong, China
• Shandong Provincial Hospital — Jinan, Shandong, China
• Liaocheng People's Hospital — Liaocheng, Shandong, China
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
• Taian City Central Hospital — Taian, Shandong, China
• Shanghai Jiaotong University School of Medicine Ruijin Hospital — Shanghai, Shanghai Municipality, China
• Renji Hospital Affliated to Shanghai Jiaotong University — Shanghai, Shanghai Municipality, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• Kunming Medical College Affiliated First Hospital — Kunming, Yunnan, China
• The First People's Hospital of Yunnan Province — Kunming, Yunnan, China
• The Second Affiliated Hospital of Zhejiang University School of Med — Hangzhou, Zhejiang, China
• First Affiliated Hosp of College of Med, Zhejiang University — Hangzhou, Zhejiang, China
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China
• The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university — Wenzhou, Zhejiang, China
• Tongji Hospital of Tongji University — Wuhan, China
• The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA — Chongqing, Chongqing Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.