PRA023 for Systemic Sclerosis with Interstitial Lung Disease
Trial Objectives
Researchers are studying a new medication called PRA023 that has anti-inflammatory and antifibrotic properties to determine how well it works against systemic sclerosis (SSc) with interstitial lung disease (ILD). The goal of this study is to understand how safe and effective PRA023 is as a treatment option as compared to a placebo (an inactive substance that looks the same and is administered the same way as PRA023) for people for diagnosed with SSc-ILD. Study participants will receive monthly IV infusions and breathing tests, along with other assessments. If eligible, participants also may enter an open label extension for another 50 weeks, where they will receive active PRA023.
Who Can Participate
People with a confirmed diagnosis of Systemic Sclerosis (SSc) with SSc-related Interstitial Lung Disease (ILD)
Age: 18+ Gender: Any
Estimated Time Commitment
Monthly visits over 50-week timeframe
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
Prometheus Biosciences
Principal Investigators
Mehrnaz Maleki Fischbach, MD