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Active, not recruiting Phase 1/2

An Open-label Phase I/II Study of JR-446 in Mucopolysaccharidosis Type IIIB

NCT06488924 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1/2
Started
2024-11-05
Last updated
2026-10-01

Condition(s) studied

Mucopolysaccharidosis III-B

Investigational drug(s) / intervention(s)

JR-446 →

JR-446: IV infusion

Study summary

A Phase I/ II, open-label study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIB patients.

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Chronological age of \<18 years * Confirmed diagnosis of MPS IIIB Exclusion Criteria: * Prior experience to gene therapy or HSCT with successful engraftment * Past use of another investigational drug or product in last 4 months or 5 half-lives (whichever is longer) before signing ICF * Current participation in a clinical trial or past participation (within 30 days of enrolment into this study) in a study involving invasive procedures * Past use of Genistein or Kineret (anakinra) within 4 months before signing ICF * Serious drug allergy or hypersensitivity * Contraindication for lumbar puncture or MRI * History of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following lumbar puncture The above information is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial.

Primary outcome measure(s)

  • To establish the safety and tolerability of JR-446 in MPSIIIB patients — up to 4 years (multiple visits)
  • To determine the pharmacodynamic effects of JR-446 in MPSIIIB patients — up to 4 years (multiple visits)

Trial sites (4)

FacilityCityRegionStatus
Hiroshima University Hospital Hiroshima Japan
University of the Ryukyus Hospital Okinawa Japan
National Center for Child Health and Development Tokyo Japan
Mie University Hospital Tsu Japan

More JCR Pharmaceuticals Co., Ltd. trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06488924 on ClinicalTrials.gov ↗ ← All trials in Japan