Last updated on July 2018

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis


Brief description of study

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.

Detailed Study Description

The total study duration per patient will be 39 weeks; consisting of a 4-week screening, a 24-week of study treatment period, and a 11-week follow-up with no study drug treatment.

Clinical Study Identifier: NCT02921971

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Investigational Site Number 6420002
Targu Mures, Romania
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