PRA023 in Systemic Sclerosis Associated With Interstitial Lung Disease

Summary

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.


Inclusion Criteria

  • Confirmed diagnosis of systemic sclerosis with onset of disease ≤ 5 years ago.
  • Diffuse cutaneous scleroderma
  • Systemic sclerosis related interstitial lung disease confirmed by HRCT
  • FVC ≥ 45% of predicted normal
Show more

Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Other

Principal Investigator

Boin, Francesco

Age Group

Adult

Phase

II

IRB Number

STUDY00001970

ClinicalTrials.gov ID

NCT05270668

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Boin, Francesco

Age Group

Adult

Phase

II

IRB Number

PR200-104

ClinicalTrials.gov ID

NCT05270668

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?