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

Study acronym: ENSURE-1
StatusActive, Not Recruiting
PhasePhase 3
SponsorImmunic AG
Started

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Record History

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  1. Trial sites expanded: 91 → 103 locations
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Sep 2024 to Nov 2026v9 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1050 to confirmed 1121
    • Study sites: 86 to 91
    • Study completion date: Sep 2032 to Sep 2033
  3. Study sites: 81 to 86v8
  4. Study sites: 59 to 81v7
  5. Study sites: 43 to 59v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 27 to 43v5
  2. Study sites: 20 to 27v4
  3. Study sites: 1 to 20v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2021 to Nov 18, 2021
    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-1)
Trial Details
NCT Number NCT05134441
Lead Sponsor Immunic AG
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 1,121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov