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NCT03518086 · ClinicalTrials.gov registry record · Phase 3
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,281
- Enrollment target
NCT03518086: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT03518086 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,281 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03518086, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,281 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from
Interventions
- DRUG Placebo
- DRUG Mirikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,281 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2024-05-15 |
| Phase | Phase 3 |
What the finished NCT03518086 record still lists
NCT03518086 is an interventional study that assigns participants to a tested intervention. Its 1,281 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03518086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03518086 about?
NCT03518086 is a clinical study titled "An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)". 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.
What is the current status of trial NCT03518086?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,281 participants. The study started on 2018-06-18. Estimated completion is 2024-05-15.
What interventions are being tested in trial NCT03518086?
The interventions under investigation include: Placebo (DRUG), Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT03518086?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03518086's enrollment target sits among peer trials
1,281 198th of 2000 higher than 1,803 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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