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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 (Ssc-ILD)

IRB Number: 2022-0436

Institutional Review Board, Hospital for Special Surgery

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Jessica K. Gordon, MD

Co-Investigators

Robert F. Spiera, MD
Lindsay S. Lally, MD
David R. Fernandez, MD, PhD
Kimberly Lakin, MD, MS
 

Summary

This is a study to investigate the treatment of Interstitial Lung Disease (ILD) with PRA023. The trial consists of weekly infusions of PRA023/placebo every 4 weeks, for 52 weeks. There are currently no patients enrolled at HSS, but this study has enrolled subjects at sites across multiple countries. 

Inclusion/Exclusion Criteria

Patients must be within five years of their first non-RP symptom associated with scleroderma, and also have scleroderma-associated ILD. Patients cannot have another inflammatory connective tissue disorder. There are other criteria to enter the study, which can be discussed with your treating physician.

Contact Information

Mia Diaz
212.774.7620
diazmia@hss.edu