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Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects

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Trial Profile

Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment of Stargardt Disease in Adolescent Subjects

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs Tinlarebant (Primary)
  • Indications Stargardt disease
  • Focus Registrational; Therapeutic Use
  • Acronyms DRAGON
  • Sponsors Belite Bio

    • Most Recent Events

    • 27 Feb 2025 According to a Belite Bio media release, this trial is expected to complete by Q4 2025 (including a three-month follow-up period).
    • 27 Feb 2025 According to a Belite Bio media release, the company has completed a planned interim analyses which was performed when all subjects completed the one-year assessment. An independent Data Safety Monitoring Board (DSMB) for this study has recommended to continue without any modifications, maintaining the sample size at 104 subjects based on the treatment effect observed at the Interim Analysis. In addition, the DSMB recommended to submit the data for further regulatory review for drug approval.
    • 27 Feb 2025 Interim results published in the Belite Bio Media Release.

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