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NCT03519945 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 3
Development phase
1,063
Enrollment target
20
Study locations

NCT03519945: Active Phase 3 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.

NCT03519945 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 1,063 participants, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03519945, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,063 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Clinical remission based on the modified Mayo Score (MMS).

Conditions Studied

Interventions

  • DRUG Mirikizumab

Study Locations (20)

Florida

  • Direct Helpers Research Center - Hialeah
  • Encore Borland-Groover Clinical Research - Jacksonville
  • Wellness Clinical Research - Miami Lakes
  • AdventHealth Orlando - Orlando
  • Clintheory Healthcare - Orlando
  • Gastroenterology Associates of Pensacola, PA - Pensacola
  • Florida Medical Clinic LLC - Zephyrhills

California

  • InSite Digestive Health Care - Arcadia
  • Care Access - Berkeley - Berkeley
  • Om Research LLC - Lancaster
  • California Medical Research Associates - Northridge
  • Inland Empire Clinical Trials, LLC - Rialto
  • Clinical Applications Laboratories, Inc. - San Diego

Arizona

  • Research Solutions of Arizona - Litchfield Park
  • Valleywise Health Medical Center - Phoenix

Alabama

  • Digestive Health Specialists - Dothan

Georgia

  • Digestive Healthcare of Georgia - Atlanta

Idaho

  • Grand Teton Research Group - Idaho Falls

Illinois

  • NorthShore University HealthSystem - Evanston Hospital - Evanston

Indiana

  • Indiana University Health University Hospital - Indianapolis

Trial Details

FieldValue
Enrollment Target 1,063 participants
Start Date 2018-07-18
Est. Completion 2027-12
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the registry record for NCT03519945 still lists

NCT03519945 is an interventional study that assigns participants to a tested intervention. Its 1,063 participants enrollment target places it among the larger protocols in the corpus, below the 2,049-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (48% lower).

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Mirikizumab is the first listed.

NCT03519945 names 20 study sites across 8 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT03519945 about?

NCT03519945 is a clinical study titled "A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)". 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 th...

What is the current status of trial NCT03519945?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,063 participants. The study started on 2018-07-18. Estimated completion is 2027-12.

What conditions does trial NCT03519945 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT03519945?

The interventions under investigation include: Mirikizumab (DRUG).

Who is sponsoring clinical trial NCT03519945?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03519945 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ulcerative Colitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03519945's enrollment target sits among peer trials

1,063 9th of 122 higher than 114 of 122 other Ulcerative Colitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03519945, the US trial registry maintained by the National Library of Medicine. NCT03519945 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.