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A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS)

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Trial Profile

A Phase 1-3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ION363 in Amyotrophic Lateral Sclerosis Patients With Fused in Sarcoma Mutations (FUS-ALS)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Ulefnersen (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus First in man; Registrational; Therapeutic Use
  • Acronyms FUS-ALS; FUSION
  • Sponsors Ionis Pharmaceuticals

    • Most Recent Events

    • 28 Mar 2024 Planned number of patients changed from 77 to 95.
    • 14 Sep 2023 Planned End Date changed from 1 Sep 2025 to 1 Mar 2028.
    • 14 Sep 2023 Planned primary completion date changed from 1 Jun 2025 to 1 Jun 2026.

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