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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Study sites: 3 to 4
    • Eligibility criteria expanded, about 9 words
  2. Primary completion date: Jun 5, 2026 to Apr 30, 2030v3 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Dec 5, 2028 to Apr 30, 2030
    • Secondary endpoints: 3 to 2
    • Site details revised at 2 of 3 sites
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2027 to Jun 5, 2026
    • Study completion date: Sep 30, 2029 to Dec 5, 2028
    • Start date changed from estimate of Aug 31, 2024 to Nov 5, 2024
    • Site details revised at 3 of 3 sites
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06488924
Lead Sponsor JCR Pharmaceuticals Co., Ltd.
Conditions
(from sponsor)		 Mucopolysaccharidosis III-B
Related terms Mucopolysaccharidosis III
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov