An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Key facts

Study ID

NCT03518086

Run by

Eli Lilly and Company

People needed

1281

Starts

2018-06-18

Expected to finish

2024-05-15

Last updated by the study team

2025-05-31

Who can join

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

You may qualify if…

• Diagnosis of UC for at least 3 months prior to baseline.
• Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
• Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
• If female, must meet the contraception requirements.

You may not qualify if…

• Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
• Participants with a previous colectomy.
• Participants with current evidence of toxic megacolon.
• Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Where it is running

• Dcr-Pi, Pc — Litchfield Park, Arizona, United States
• Maricopa Integrated Health System — Phoenix, Arizona, United States
• Physicians Research Group — Tempe, Arizona, United States
• Yuma Gastro LLC — Yuma, Arizona, United States
• Valley Gastroenterology — Arcadia, California, United States
• Care Access Research — Berkeley, California, United States
• Citrus Valley Health Partners — Covina, California, United States
• Valley View Internal Medicine — Garden Grove, California, United States
• Om Research, LLC — Lancaster, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• California Medical Research Associates — Northridge, California, United States
• Gastroenterology Associates — Pasadena, California, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• UCSF Medical Center at Mission Bay — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Delta Waves Sleep Disorders and Research Center — Colorado Springs, Colorado, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
• Pioneer Clinical Research — Coral Springs, Florida, United States
• Direct Helpers Medical Center — Hialeah, Florida, United States
• The Center for Gastrointestinal Disorders — Hollywood, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• SIH Research, LLC — Kissimmee, Florida, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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