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 …
Primary Objectives: To evaluate the safety and tolerability of isatuximab administered subcutaneously (SC) versus intravenously (IV) To evaluate the pharmacokinetics (PK) of SC and IV isatuximab Secondary Objectives: To estimate absolute bioavailability of SC and IV isatuximab To measure receptor occupancy (RO) after isatuximab SC versus IV administration To assess …
Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: To characterize the long-term efficacy of fitusiran as assessed by the frequency of: Bleeding episodes Spontaneous bleeding episodes Target joint bleeding episodes To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants …
Primary Objectives: Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to …
Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD) Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation To continue to assess the …
Primary Objective: To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to <12 years of age) with severe hemophilia A or B Secondary Objective: To characterize the safety and tolerability To characterize the pharmacokinetics (PK)
Primary Objectives: To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function To assess the safety and tolerability of lademirsen (SAR339375) in subjects with Alport syndrome Secondary Objectives: To assess plasma pharmacokinetic (PK) parameters of the parent compound and its metabolites To assess the potential formation …
This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.
Primary Objectives: To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function To assess the safety and tolerability of lademirsen (SAR339375) in subjects with Alport syndrome Secondary Objectives: To assess plasma pharmacokinetic (PK) parameters of the parent compound and its metabolites To assess the potential formation …
The purpose of this study is to see if the new study drug, Ziltivekimab, can be used to treat people with cardiovascular disease, chronic kidney disease, and inflammation. The ZEUS study will see if Ziltivekimab can reduce the risk of having cardiovascular events (for example, heart attack and stroke). The …
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