Femme et Homme
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Extrait
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in patients with dcSSc. Secondary Objectives: - To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in patients with dcSSc. - To evaluate the efficacy of SAR156597 compared to placebo on respiratory function in patients with dcSSc. - To evaluate the safety profile of SAR156597 compared to placebo in patients with dcSSc. - To evaluate the potential for immunogenicity (anti-drug antibodies [ADA] response) of SAR156597 in patients with dcSSc. - To evaluate the pharmacokinetics (PK) (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.
Critère d'inclusion
- Systemic Sclerosis