What is the Purpose of this Study?
This study focuses on individuals who have systemic sclerosis associated with interstitial lung disease (SSc-ILD). Systemic sclerosis is an autoimmune disease in which the immune system starts attacking its own cells. The study will evaluate the safety and effectiveness of an investigational drug called PRA023 in SSc-ILD patients. PRA023 consists of man-made antibodies that act like human antibodies; it has anti-inflammatory and anti-fibrotic (slowing down rate of fibrosis) properties. PRA023 will be compared with a placebo (inactive substance).
Researchers will also assess how the body processes PRA023 by measuring the levels of PRA023 in the blood (pharmacokinetics), as well as the effect of PRA023 on biomarkers (pharmacodynamics). Biomarkers are substances in the body that help in predicting the status of a disease or condition.
Eligibility
- Has confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
- Has diffuse cutaneous scleroderma
- Has systemic sclerosis related interstitial lung disease confirmed by HRCT
- FVC ≥ 45% of predicted normal
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease