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Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Sanofi · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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systemic-sclerosis
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.
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