Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

NCT ID: NCT03068234

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pirfenidone group

The subjects will receive pirfenidone from 200mg three times a day, oral administrated, with low dose steroids.

Group Type: EXPERIMENTAL

Pirfenidone

Intervention Type: DRUG

A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.

Steroids

Intervention Type: DRUG

Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Control group

The subjects will receive placebo within first 24-week, and pirfenidone 200mg three times a day for the second 24-week, with low dose steroids.

Group Type: PLACEBO_COMPARATOR

Pirfenidone

Intervention Type: DRUG

A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.

Placebo oral capsule

Intervention Type: DRUG

Placebo for pirfenidone capsule

Steroids

Intervention Type: DRUG

Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Interventions

Pirfenidone

A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.

Intervention Type: DRUG

Placebo oral capsule

Placebo for pirfenidone capsule

Intervention Type: DRUG

Steroids

Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Fulfill EULAR/ACR classification criteria (2013) for systemic sclerosis (SSc).
• Subjects must have mRSS≥10 at screening stage
• Subjects must have signs of fibrosis in their chest CT at screening stage
• If a subject has received treatments before, it should be stable at least 3 months until screening and with no significant efficacy (ΔmRSS≤-2)

Exclusion Criteria

• Subjects with other connective tissue diseases overlapping with SSc
• Subjects with skin atrophy as the main cutaneous manifestation
• Subjects with active digital ulcers or gangrene
• Active severe SSc-driven renal disease or heart dysfunction at screening
• Subjects with significant hematologic abnormalities
• Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level
• Clinically significant active infection including ongoing and chronic infections
• History of human immunodeficiency virus (HIV)
• Confirmed Positive tests for hepatitis B or positive test for hepatitis C
• Active tuberculosis
• Live or attenuated vaccine within 4 weeks prior to screening
• Subjects with significant hematologic abnormalities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

RenJi Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

[2017]17

Identifier Type: -

Identifier Source: org_study_id