Systemic Sclerosis Clinical Trial
Official title:
Efficacy and Safety of SAR156597 in the Treatment of Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Randomized, Double-blind, Placebo-controlled, 24-week, Proof of Concept Study
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: - To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. - To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. - To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. - To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. - To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.
The total study duration per participant was 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and an 11-week follow-up with no study drug treatment. ;
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