Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Active, not recruiting
Sanofi
Phase 2
Primary Objective:
To determine the long-term safety and tolerability of SAR442168 in RMS participants
Secondary Objective:
To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging
methods
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Recruiting
Sanofi
Phase 3
Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide
(Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with
relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability
progression, MRI lesions, cognitive performance and quality of life To evaluate the safety
and tolerability of daily SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168
and relevant metabolites and its relationship to efficacy and safety To evaluate
pharmacodynamics (PD) of SAR442168
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Recruiting
Sanofi
Phase 3
Primary Objective:
To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide
(Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with
relapsing forms of MS
Secondary Objective:
To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability
progression, MRI lesions, cognitive performance and quality of life To evaluate the safety
and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168
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