Clinical Trial: Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Concep

Brief Summary:

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.