Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis

NCT03068234 | Unknown Phase 2

• 1 other identifier: [2017]17
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Modified Rodnan Skin Score (mRSS）

  A semi-quantitative score for skin fibrosis of every subjects

  Week 52

Secondary Outcomes (17)

• Modified Rodnan Skin Score

  Week 24

• Assessment of chest CT

  Week 52

• Assessment of chest CT

  Week 24

• Forced vital capacity

  Week 52

• Forced vital capacity

  Week 24

Study Arms (2)

Pirfenidone group

EXPERIMENTAL

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

Drug: Pirfenidone; Drug: Steroids

Control group

PLACEBO COMPARATOR

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.

Drug: Pirfenidone; Drug: Placebo oral capsule; Drug: Steroids

Interventions

Pirfenidone DRUG

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

Control group; Pirfenidone group

Placebo oral capsule DRUG

Placebo for pirfenidone capsule

Control group

Steroids DRUG

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

Control group; Pirfenidone group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

pirfenidone; Steroids

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: May 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

CN (1)