Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Study acronym: ENSURE-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorImmunic AG
Started

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Record History

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  1. Trial sites expanded: 76 → 101 locations
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 4 of 5 entries
  2. Primary completion date: Oct 2024 to Nov 2026v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1050 to confirmed 1100
    • Study sites: 91 to 76
    • Study completion date: Oct 2032 to Oct 2033
  3. Study sites: 86 to 91v7
  4. Study sites: 68 to 86v6
  5. Study sites: 52 to 68v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 29 to 52v4
  2. Study sites: 15 to 29v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 15
    • Start date changed from estimate of Jan 2022 to Jan 12, 2022
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT05201638
Lead Sponsor Immunic AG
Conditions
(from sponsor)		 Multiple Sclerosis, Relapsing-Remitting
Related terms Multiple Sclerosis, Relapsing-Remitting
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov