Trials / Enrolling By Invitation

Enrolling By InvitationNCT05594992

An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in MPS II (Hunter Syndrome) Subjects

An Extension Study of JR-141 to Evaluate the Long-term Safety and Efficacy in Mucopolysaccharidosis Type II (Hunter Syndrome) Subjects

Status: Enrolling By Invitation
Phase: Phase 3
Study type: Interventional
Enrollment: 80 (estimated)

Sponsor: JCR Pharmaceuticals Co., Ltd. · Industry
Sex: All
Age: —
Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	JR-141	IV infusion, 2.0 mg/kg/week

Timeline

Start date: 2023-02-22
Primary completion: 2028-02-28
Completion: 2028-02-28
First posted: 2022-10-26
Last updated: 2026-01-21

Locations

10 sites across 8 countries: United States, Argentina, Brazil, France, Germany, Italy, Poland, Spain

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05594992. Inclusion in this directory is not an endorsement.