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

RECRUITING Phase 3

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

NCT04844606 · View on ClinicalTrials.gov ↗

Study Summary

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Interventions

  • DRUG Mirikizumab

Study Locations (20)

Other

  • Medizinische Universität Wien — Vienna
  • UZ Brussel — Brussels
  • Cliniques universitaires Saint-Luc — Brussels
  • Antwerp University Hospital — Edegem
  • UZ Gent — Ghent
  • UZ Leuven — Leuven
  • Centro de Pesquisa Sao Lucas — Campinas
  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância — Curitiba
  • Universidade Federal de Goias — Goiânia
  • Hospital de Clinicas de Porto Alegre — Porto Alegre

Georgia

  • Emory University School of Medicine — Atlanta
  • Children's Center for Digestive Health Care, LLC — Atlanta

Massachusetts

  • Boston Children's Hospital — Boston
  • Massachusetts General Hospital — Waltham

California

  • UCSF Medical Center at Mission Bay — San Francisco

Connecticut

  • Connecticut Children's Medical Center — Hartford

Missouri

  • Washington University School of Medicine — St Louis

New York

  • Icahn School of Medicine at Mount Sinai — New York

Texas

  • Cook Children's Medical Center — Fort Worth

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-05-26
Est. Completion 2030-12
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 NCT04844606

The ClinicalTrials.gov registry entry for NCT04844606 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 150 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 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention — of which Mirikizumab 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: NCT04844606 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Georgia, Massachusetts. 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 NCT04844606 about?

NCT04844606 is a clinical study titled "A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)". The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continu...

What is the current status of trial NCT04844606?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2021-05-26. Estimated completion is 2030-12.

What conditions does trial NCT04844606 study?

This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Diseases, Ulcerative Colitis Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04844606?

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

Who is sponsoring clinical trial NCT04844606?

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 NCT04844606 being conducted?

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