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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,050
Patients are randomized to IMU-838 or placebo in ratio 1:1
Patients are randomized to IMU-838 or placebo in ratio 1:1
To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.
Time frame: 72 weeks
Effect of IMU-838 versus placebo on volume of new T2 lesions
To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838- and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period.
Time frame: 72 weeks
Effect of IMU-838 versus placebo on disability progression
To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks.
Time frame: 72 weeks
Effect of IMU-838 versus placebo on cognitive performance
To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72-weeks.
Time frame: 72 weeks
Effect of IMU-838 versus placebo on whole brain atrophy
To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period.
Time frame: 72 weeks
Safety of IMU-838 versus placebo
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Xenoscience, Inc., 21st Century Neurology
Phoenix, Arizona, United States
RECRUITINGBradenton Research Center
Bradenton, Florida, United States
RECRUITINGReliant Medical Research, LLC
Miami, Florida, United States
WITHDRAWNCollier Neurologic Specialists
Naples, Florida, United States
RECRUITINGNeurology Associates of Ormond Beach
Ormond Beach, Florida, United States
RECRUITINGConsultants in Neurology, Ltd
Northbrook, Illinois, United States
RECRUITINGKlinika Mjekesore Nuova, Neurology Clinic
Tirana, Albania
RECRUITINGHygeia Hospital Tirana
Tirana, Albania
RECRUITINGMHAT Puls AD
Blagoevgrad, Bulgaria
RECRUITINGMHAT "Heart and Brain", EAD
Burgas, Bulgaria
RECRUITING...and 76 more locations
To evaluate safety and tolerability of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations.
Time frame: 72 weeks