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A Long-Term Study of JNT-517 in Participants With Phenylketonuria

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 45 → 240 participants Trial arms changed: 4 → 1 · Interventions: JNT-517 Tablet (Drug) to JNT-517 (Drug) · Eligibility criteria expanded, about 179 words · 3 morev5 Show 6 more changesShow less
    • Trial arms changed: 4 → 1
    • Interventions: JNT-517 Tablet (Drug) to JNT-517 (Drug)
    • Eligibility criteria expanded, about 179 words
    • Secondary endpoints: 3 to 11
    • Primary endpoint revised
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 12 · Primary completion date: Nov 2027 to Nov 1, 2027 · Completion date: Feb 2028 to Feb 1, 2028 · 1 morev4 Show 4 more changesShow less
    • Study sites: 0 to 12
    • Primary completion date: Nov 2027 to Nov 1, 2027
    • Completion date: Feb 2028 to Feb 1, 2028
    • Start date changed from estimate of Jun 2025 to Aug 11, 2025
  3. Lead sponsor: Jnana Therapeutics to Otsuka Pharmaceutical Development & Commercialization, Inc.v3
  4. Start date: Nov 2024 to Jun 2025v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201 (NCT06637514) as well as participants who have not participated in a prior JNT-517 study. In this trial, all participants will receive JNT-517 using age- and weight-banded dosing as outlined in the protocol, regardless of any dose received in a previous study.
Trial Details
NCT Number NCT06628128
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Phenylketonuria (PKU)
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov