At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating SAR156597 and Placebo for Systemic Sclerosis. Completed, enrolled 97 participants across 44 sites in 13 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Pharmaceutical form: Solution Route of administration: Subcutaneous
Pharmaceutical form: Solution Route of administration: Subcutaneous