An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects
NCT05594992 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-01-21
Summary
An extension of Global Phase III open-label, multicenter designed to evaluate the Long-term 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
Sponsors & Collaborators
-
JCR Pharmaceuticals Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-22
- Primary Completion
- 2028-02-28
- Completion
- 2028-02-28
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- France
- Germany
- Italy
- Poland
- Spain
Study Locations
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