A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Primary Objective:
To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS
Secondary Objective:
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 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168
This was an event-driven (6-month CDP) trial with a variable treatment duration (end-of-study [EOS] duration: up to approximately 47months).
Participants with 6-month confirmed disability progression (CDP) had an option to receive tolebrutinib in the open-label (OL).
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
San Francisco, California 94158, United States
Basalt, Colorado 81621, United States
Kansas City, Kansas 66160-7321, United States
Lexington, Kentucky 40509, United States
New York, New York 10029-6501, United States
Philadelphia, Pennsylvania 19104, United States
Burlington, Vermont 05401, United States
Capital Federal, Buenos Aires 1012, Argentina
CABA, Buenos Aires F.D. C1061, Argentina
Ostrava - Poruba, 70852, Czechia
Moriguchi-shi, Osaka 570-8507, Japan
Kawagoe-shi, Saitama 350-8550, Japan
Kodaira-shi, Tokyo 187-8551, Japan
Ube-shi, Yamaguchi 755-8505, Japan
Sagamihara-shi, 252-0392, Japan
Sittard-Geleen, 6162 BG, Netherlands