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NCT04573023 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
A Phase 3 study of Mucopolysaccharidosis II, sponsored by JCR Pharmaceuticals Co..
- Active
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT04573023: Active Phase 3 study of Mucopolysaccharidosis II, sponsored by JCR Pharmaceuticals Co..
NCT04573023 is a Phase 3 study of Mucopolysaccharidosis II that is active but no longer recruiting, run by JCR Pharmaceuticals Co.. The registered enrollment target is 86 participants, above the 61-participant average among 7 other Mucopolysaccharidosis II trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04573023, a Phase 3 study of Mucopolysaccharidosis II, is active but no longer recruiting, sponsored by JCR Pharmaceuticals Co..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
Conditions Studied
Interventions
- DRUG JR-141
- DRUG Idursulfase
- DRUG JR-141 or Idursulfase
Study Locations (20)
Other
- Hospital Universitario Austral - Buenos Aires
- Hospital de Clínicas de Porto Alegre - Porto Alegre
- Instituto de Genética e Erros Inatos do Metabolismo - São Paulo
- Fundación Cardio Infantil - Instituto de Cardiología - Bogotá
- Hôpital Femme Mère Enfant - Bron
- Hôpital Armand Trousseau - Paris
- Universitätsklinikum Giessen - Giessen
- Universitätsklinikum Hamburg-Eppendorf - Hamburg
- SphinCS GmbH - Höchheim
- Universitätsmedizin Mainz - Mainz
- Ha'Emek Medical Center - Afula
- Osp. Pediatrico Bambino Gesù, IRCCS - Rome
- Uniwersytecki Szpital Dziecięcy - Krakow
Arizona
- Phoenix Children's Hospital - Phoenix
California
- UCSF Benioff Children's Hospital Oakland - Oakland
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Minnesota
- University of Minnesota - Minneapolis
New York
- Columbia University - New York
North Carolina
- University of North Carolina at Chapel Hill Medical School Wing E - Chapel Hill
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2022-02-14 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 3 |
What the registry record for NCT04573023 still lists
NCT04573023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 61-participant average among 7 other Mucopolysaccharidosis II trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Mucopolysaccharidosis II appearing as the primary indexed condition, and to 3 interventions - of which JR-141 is the first listed.
NCT04573023 names 20 study sites across 8 states, led by Other, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04573023 about?
NCT04573023 is a clinical study titled "A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)". A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.
What is the current status of trial NCT04573023?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2022-02-14. Estimated completion is 2027-10-31.
What conditions does trial NCT04573023 study?
This clinical trial studies the following conditions: Mucopolysaccharidosis II.
What interventions are being tested in trial NCT04573023?
The interventions under investigation include: JR-141 (DRUG), Idursulfase (DRUG), JR-141 or Idursulfase (DRUG).
Who is sponsoring clinical trial NCT04573023?
This trial is sponsored by JCR Pharmaceuticals Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04573023 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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