Status and phase
Conditions
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Study type
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Identifiers
About
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
Full description
Study duration will vary per participant in this event driven trial with a treatment duration of approximately 24 to 48 months.
Participants completing the treatment period will be proposed to enroll in a separate long term safety study.
Enrollment
Sex
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Inclusion and exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
1,131 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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