Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Status:
Completed
Trial end date:
2019-04-01
Target enrollment:
Participant gender:
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.