Bradenton Research Center | Bradenton, FL
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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)
Full description
This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:
Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female patient (age ≥18 to ≤55 years).
Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
Active disease as defined by Lublin 2014 evidenced prior to Screening by:
Willingness and ability to comply with the protocol.
Written informed consent given prior to any study-related procedure.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,050 participants in 2 patient groups, including a placebo group
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Central trial contact
Andreas Muehler, MD
Data sourced from clinicaltrials.gov
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