NCT03068234

Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

A Randomized, Double-blinded, Placebo Controlled Study to Evaluate Clinical Efficacy and Safety of Pirfenidone for Skin Fibrosis in Systemic Sclerosis

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy and safety of an antifibrotic agent, pirfenidone as treatment of systemic sclerosis. The primary outcome of this study is improvement of skin fibrosis.

Detailed description

All patients enrolled should suffer from moderate to severe skin fibrosis at the screening stage. The study period is 52 week. The study contains two stages, a 24-week blind stage following with open stage for another 24-week period of time. Subjects will receive pirfenidone or placebo randomized in the first 24-week and will all receive pirfenidone treatment in the second 24-week, with of combination of low dose steroids. The secondary outcomes of this study include but not limit to safety, improvement of lung fibrosis and digital ulcer burden.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	Pirfenidone	A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.
DRUG	Placebo oral capsule	Placebo for pirfenidone capsule
DRUG	Steroids	Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-04-01
• Completion: 2019-12-01
• First posted: 2017-03-01
• Last updated: 2017-03-01

Locations

1 site across 1 country: China