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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-2)

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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-2)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Vidofludimus calcium (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENSURE-2
  • Sponsors Immunic

    • Most Recent Events

    • 08 Aug 2024 According to an Immunic media release, an interim futility analysis of the ENSURE program is expected in the fourth quarter of 2024. Company is on track with phase 3 ENSURE program in RMS and expect to complete the first ENSURE trial in the second quarter of 2026 and the second ENSURE trial in the second half of 2026.
    • 08 May 2024 According to an Immunic media release, read outs of this second ENSURE trial is anticipate in the second half of 2026
    • 23 Feb 2023 According to an Immunic media release, interim analysis data of this study is expected in late 2024.

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