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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 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.

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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).

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

FieldValue
Enrollment Target 1,177 participants
Start Date 2018-10-19
Est. Completion 2025-02-17
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT03524092

The ClinicalTrials.gov registry entry for NCT03524092 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,177 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (43% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.