NCT02921971

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	SAR156597	Pharmaceutical form: Solution Route of administration: Subcutaneous
DRUG	Placebo	Pharmaceutical form: Solution Route of administration: Subcutaneous

Timeline

• Start date: 2016-12-21
• Primary completion: 2019-01-14
• Completion: 2019-04-01
• First posted: 2016-10-03
• Last updated: 2022-03-21
• Results posted: 2022-02-02

Locations

44 sites across 13 countries: United States, Argentina, Belgium, Estonia, France, Germany, Italy, Mexico, Poland, Romania, Russia, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study