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A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)

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Trial Profile

A Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 Versus Placebo in Adults With Relapsing Multiple Sclerosis (ENSURE-1)

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

Latest Information Update: 12 Jun 2025

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At a glance

  • Drugs Vidofludimus calcium (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENSURE-1
  • Sponsors Immunic

Most Recent Events

  • 05 Jun 2025 According to an Immunic media release, topline data from this trial is expected in YE 2026.
  • 05 Jun 2025 According to an Immunic media release, status changed from recruiting to active, no longer recruiting.
  • 22 Oct 2024 According to an Immunic media release,company announced a positive outcome of the non-binding, interim futility analysis of its phase 3 ENSURE program

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