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A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis

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Trial Profile

A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Jun 2025

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At a glance

  • Drugs BIIB 091 (Primary) ; Diroximel-fumarate (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FUSION
  • Sponsors Biogen

Most Recent Events

  • 22 Jun 2025 Planned End Date changed from 9 Nov 2026 to 7 Sep 2027.
  • 22 Jun 2025 Planned primary completion date changed from 10 Jul 2025 to 7 Sep 2027.
  • 13 Oct 2023 Study design presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis

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