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NCT05509777 · ClinicalTrials.gov registry record · Phase 3

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

A Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.

Recruiting
Registry status
Phase 3
Development phase
90
Enrollment target
20
Study locations

NCT05509777 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 90 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05509777, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Eli Lilly and Company.

RECRUITING
Registry status
Phase 3
Development phase
90 participants
Enrollment target
20
Study locations

Study Summary

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

Conditions Studied

Crohn's Disease

Interventions

  • DRUG Mirikizumab

Study Locations (20)

Other

  • AKH - Medizinische Universtität Wien - Vienna
  • Universitair Ziekenhuis Brussel - Brussels
  • Cliniques universitaires Saint-Luc - Brussels
  • Universitair Ziekenhuis Gent - Ghent
  • UZ Leuven - Leuven

New York

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) - New York
  • Icahn School of Medicine at Mount Sinai - New York
  • Columbia University Medical Center/New York Presbyterian - New York

Georgia

  • Emory University - Atlanta
  • Children's Center for Digestive Health Care, LLC - Atlanta

California

  • Cedars Sinai Medical Center - Los Angeles

Connecticut

  • Connecticut Children's Medical Center - Hartford

Indiana

  • Riley Childrens Hospital - Indianapolis

Massachusetts

  • Boston Children's Hospital - Boston

New Jersey

  • Atlantic Children's Health--Pediatric Gastroenterology - Morristown

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2024-03-13
Est. Completion 2028-04
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

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What the Registry Record Tells You About NCT05509777

The ClinicalTrials.gov registry entry for NCT05509777 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (96% 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 Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Mirikizumab is the first listed.

NCT05509777 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, New York, Georgia.

Frequently Asked Questions

What is clinical trial NCT05509777 about?

NCT05509777 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease". Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn'...

What is the current status of trial NCT05509777?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2024-03-13. Estimated completion is 2028-04.

What conditions does trial NCT05509777 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT05509777?

The interventions under investigation include: Mirikizumab (DRUG).

Who is sponsoring clinical trial NCT05509777?

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

Where is trial NCT05509777 being conducted?

This trial has 20 study locations across California, Connecticut, Georgia, Indiana, Massachusetts. 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 Editorial

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.