Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

NCT05784246 · View on ClinicalTrials.gov ↗

Study Summary

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Conditions Studied

Interventions

  • DRUG Mirikizumab IV
  • DRUG Mirikizumab SC

Study Locations (20)

Other

  • UZA — Edegem
  • UZ Leuven — Leuven
  • The Hospital for Sick Children — Toronto
  • Hôpital Necker - Enfants Malades — Paris
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz — Mainz
  • LMU-Campus Innenstadt — München
  • Helios Klinikum Wuppertal — Wuppertal
  • Shaare Zedek — Jerusalem
  • Hadassah University Hospital, Ein Kerem — Jerusalem
  • Schneider Children's Medical Center — Petah Tikva
  • King Fahad Medical City — Rishon LeZiyyon
  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer — Florence
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza — Roma
  • Juntendo University Hospital — Bunkyō City

California

  • University of California, San Francisco — San Francisco

Georgia

  • Children's Center for Digestive Health Care, LLC — Atlanta

Indiana

  • Riley Childrens Hospital — Indianapolis

Missouri

  • Washington University — St Louis

New York

  • Icahn School of Medicine at Mount Sinai — New York

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2023-11-22
Est. Completion 2026-08
Phase Phase 3

Sponsor

Eli Lilly and Company

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05784246

The ClinicalTrials.gov registry entry for NCT05784246 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Mirikizumab IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05784246 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05784246 about?

NCT05784246 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis". The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

What is the current status of trial NCT05784246?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2023-11-22. Estimated completion is 2026-08.

What conditions does trial NCT05784246 study?

This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05784246?

The interventions under investigation include: Mirikizumab IV (DRUG), Mirikizumab SC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05784246?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05784246 being conducted?

This trial has 20 study locations across California, Georgia, Indiana, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial