P3-IMU-838-RMS-01 - 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)

Relapsing Multiple Sclerosis

Time to first confirmed relapse, as determined by the Independent Neurology Evaluation Committee (INEC), relapse occurred after the start of treatment administration and before the end of the main period (EOMP), censored at a maximum of 72 weeks, Visit 8 (V8)/EOMP

Key secondary efficacy: 1) Changes in total volume of new T2-lesions from baseline (BL, SV2) magnetic resonance imaging (MRI) until Week 24 MRI;, 2) Time to 12-week confirmed disability worsening (12wCDW) as assessed on Expanded Disability Status Scale (EDSS); as defined in this protocol during the MP (censored until at Week 72/EOMP visit but with confirmation potentially done within EP, if applicable);, 3) Time to confirmed clinically relevant changes in Symbol Digit Modalities Test (SDMT) in the MP (censored Week 72/EOMP), 4) Annualized rate of percentage changes in whole brain volume from BL MRI to until V8/EOMP MRI; Please refer to protocol for secondary efficacy, safety, and exploratory endpoints.

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