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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 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.

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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

Mucopolysaccharidosis II

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

FieldValue
Enrollment Target 86 participants
Start Date 2022-02-14
Est. Completion 2027-10-31
Phase Phase 3

Sponsor

JCR Pharmaceuticals Co.

5 total trials

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What the Registry Record Tells You About NCT04573023

The ClinicalTrials.gov registry entry for NCT04573023 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 61-participant average among 7 other Mucopolysaccharidosis II trials with a reported enrollment target (41% higher). The listed sponsor is JCR Pharmaceuticals Co., which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.