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A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

NCT04573023 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-21

No results posted yet for this 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

  • Mucopolysaccharidosis II

Interventions

DRUG

JR-141

IV infusion, 2.0 mg/kg/week

DRUG

Idursulfase

IV infusion

DRUG

JR-141 or Idursulfase

The subjects who have achieved the pre-specified criteria\* are able to change the drug. \*If a subject in Idursulfase group shows decline in their neurocognitive outcome, idursulfase can be switched to JR-141. If a subject in JR-141 group shows decline in their peripheral outcome, JR-141 will be switched to idursulfase.

Sponsors & Collaborators

  • JCR Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2027-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Colombia
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04573023 on ClinicalTrials.gov