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A Phase 2, Two-part, Placebo-controlled, Parallel-group, Double-blind Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Participants 5 Years of Age and Older

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Trial Profile

A Phase 2, Two-part, Placebo-controlled, Parallel-group, Double-blind Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for the Treatment of Fibrodysplasia Ossificans Progressiva in Male and Female Participants 5 Years of Age and Older

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

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Fidrisertib (Primary)
  • Indications Fibrodysplasia ossificans progressiva
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms FALKON
  • Sponsors Blueprint Medicines; Clementia Pharmaceuticals

Most Recent Events

  • 13 Feb 2025 According to a Ipsen media release, company anticipate readout of the pivotal Phase IIb trial in fibrodysplasia ossificans progressive in 2025
  • 01 Nov 2024 Planned primary completion date changed from 30 Aug 2025 to 15 Jul 2025.
  • 20 Sep 2024 Planned End Date changed from 30 Aug 2025 to 30 Mar 2029.

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