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A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)
NCT04573023 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04573023
The ClinicalTrials.gov registry entry for NCT04573023 describes a study currently listed as active not 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 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is JCR Pharmaceuticals Co., which has 1 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 Mucopolysaccharidosis II appearing as the primary indexed condition, and to 3 interventions — of which JR-141 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: NCT04573023 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Arizona, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04573023?
The interventions under investigation include: JR-141 (DRUG), Idursulfase (DRUG), JR-141 or Idursulfase (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04573023?
This trial is sponsored by JCR Pharmaceuticals Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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