Trial intelligence / Profile preview

Pirfenidone for Skin Fibrosis in Systemic Sclerosis

NCT03068234Phase 3

Key facts

Status: Unknown
Start: May 2017
Primary completion: Apr 2019
Countries: 1
Sponsor: Renji Hospital
Modality: Small Molecules

Drugs: pirfenidone
Conditions: systemic sclerosis (SSc)

Overview

Phase 3, randomised, double-blind trial of pirfenidone in systemic sclerosis (SSc) (2 arms), sponsored by Renji Hospital. Primary endpoint: Modified Rodnan Skin Score at 52 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Pirfenidone Group
Pirfenidone 200mg TID + Low dose steroids
Control Group
Placebo + Low dose steroids (Weeks 0-24) -> Pirfenidone + Low dose steroids (Weeks 24-52)

Who it enrols

Patients with systemic sclerosis fulfilling EULAR/ACR criteria, with moderate to severe skin fibrosis (mRSS >= 10) and signs of fibrosis on chest CT. Excludes patients with active digital ulcers, severe renal/heart dysfunction, or significant hematologic/liver abnormalities.

Endpoints

Primary

Modified Rodnan Skin Score52 weeks

Secondary

Modified Rodnan Skin Score24 weeks
Assessment of chest CT52 weeks
Forced Vital Capacity52 weeks
Diffusing Capacity of the Lung for Carbon Monoxide52 weeks
6 Minute Walk Test52 weeks
Hand function assessment52 weeks
Proportion of subjects with increased mRSS52 weeks
Quality of Life52 weeks

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