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NCT03524092 · ClinicalTrials.gov registry record · Phase 3
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,177
- Enrollment target
- 20
- Study locations
NCT03524092: Completed Phase 3 study of Ulcerative Colitis, sponsored by Eli Lilly and Company.
NCT03524092 is a Phase 3 study of Ulcerative Colitis that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,177 participants, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03524092, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,177 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). 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 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on ce
Conditions Studied
Interventions
- DRUG Placebo SC
- DRUG Mirikizumab IV
- DRUG Mirikizumab SC
Study Locations (20)
Florida
- Direct Helpers Research Center - Hialeah
- Nature Coast Clinical Research, LLC - Inverness
- SIH Research, LLC - Kissimmee
- Research Associates of South Florida, LLC - Miami
- Wellness Clinical Research - Miami Lakes
- Center for Interventional Endoscopy - Orlando
- Clintheory Healthcare - Orlando
- Gastroenterology Associates of Pensacola, PA - Pensacola
- Florida Medical Clinic LLC - Zephyrhills
California
- Valley Gastroenterology - Arcadia
- Care Access Research - Berkeley
- Om Research, LLC - Lancaster
- California Medical Research Associates - Northridge
- Clinical Applications Laboratories, Inc. - San Diego
- UCSF Medical Center at Mission Bay - San Francisco
Arizona
- Dcr-Pi, Pc - Litchfield Park
- Maricopa Integrated Health System - Phoenix
- Physicians Research Group - Tempe
Alabama
- Digestive Health Specialists of the Southeast - Dothan
Georgia
- Digestive Healthcare of Georgia - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,177 participants |
| Start Date | 2018-10-19 |
| Est. Completion | 2025-02-17 |
| Phase | Phase 3 |
What the finished NCT03524092 record still lists
NCT03524092 is an interventional study that assigns participants to a tested intervention. Its 1,177 participants enrollment target places it among the larger protocols in the corpus, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo SC is the first listed.
NCT03524092 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03524092 about?
NCT03524092 is a clinical study titled "A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis". 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).
What is the current status of trial NCT03524092?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,177 participants. The study started on 2018-10-19. Estimated completion is 2025-02-17.
What conditions does trial NCT03524092 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT03524092?
The interventions under investigation include: Placebo SC (DRUG), Mirikizumab IV (DRUG), Mirikizumab SC (DRUG).
Who is sponsoring clinical trial NCT03524092?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03524092 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.
Learn More About Clinical Trials
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Where NCT03524092's enrollment target sits among peer trials
1,177 5th of 122 higher than 118 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.
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