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)
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: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,100
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 based on 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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Neuro of Central Florida
Altamonte Springs, Florida, United States
Healthcare Innovations
Coral Springs, Florida, United States
Heratsi Hospital Complex 1
Yerevan, Armenia
Saint Gregory the Illuminator Medical Center
Yerevan, Armenia
Erebouni Medical Center
Yerevan, Armenia
UCC of Rep of Srpska
Banja Luka, Bosnia and Herzegovina
Cantonal Hospital Bihac Dr. Irfan Ljubijankic
Bihać, Bosnia and Herzegovina
University Clinical Center of Sarajevo
Sarajevo, Bosnia and Herzegovina
University Clinical Center Sarajevo
Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Bosnia and Herzegovina
...and 66 more locations
To evaluate safety and tolerability by assessment of occurrence of Adverse Events.
Time frame: 72 weeks