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NCT04844606 · ClinicalTrials.gov registry record · Phase 3
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
A Phase 3 study of Ulcerative Colitis and Crohn's Disease, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT04844606 is a Phase 3 study of Ulcerative Colitis and Crohn's Disease that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 150 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT04844606, a Phase 3 study of Ulcerative Colitis and Crohn's Disease, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2030-12 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (93% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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.
NCT04844606 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Georgia, Massachusetts.
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.
What interventions are being tested in trial NCT04844606?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT04844606?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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.
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