Clinical Trials in Japan / NCT06488924
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
Condition(s) studied
Mucopolysaccharidosis III-B
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
An Extension Study of JR-141 in Patients With Mucopolysaccharidosis Type II
Active, not recruiting
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