A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Primary Progressive Multiple Sclerosis (PERSEUS)
Primary Objective:
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)
Secondary Objectives:
To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 12 to 60 months.
Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Los Alamitos, California 90720, United States
Newport Beach, California 92663, United States
San Francisco, California 94158, United States
Clearwater, Florida 33761, United States
Gainesville, Florida 32601, United States
New Orleans, Louisiana 70121, United States
Lutherville, Maryland 21093, United States
Farmington Hills, Michigan 48334, United States
New York, New York 10029-6501, United States
Durham, North Carolina 27710, United States
Winston-Salem, North Carolina 27103, United States
Columbus, Ohio 43221, United States
Greer, South Carolina 29651-1817, United States
CABA, Buenos Aires C1012AAR, Argentina
Koriyama-shi, Fukushima 963-8052, Japan
Sagamihara-shi, Kanagawa 252-0392, Japan
Moriguchi-shi, Osaka 570-8507, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Bunkyo-ku, Tokyo 113-8431, Japan
Kodaira-shi, Tokyo 187-8551, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Sittard-Geleen, 6162 BG, Netherlands