Drug Details

PRA023, is an IgG1 humanized monoclonal antibody (mAb) in development for the treatment of immune-mediated diseases, including ulcerative colitis (UC), Crohn’s disease (CD), and a recently announced third indication, systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Study Purpose

ATHENA-SSc-ILD is a placebo-controlled Phase 2 trial of PRA023 in SSc-ILD, with anticipated enrollment of approximately 100 patients who will be randomized 1:1 to either the active or placebo arm. The primary endpoint of the trial will be the annual rate of change in forced vital capacity (FVC) at 50 weeks. Secondary endpoints will be the change in quantitative interstitial lung disease by centrally-read high-resolution computed tomography (HRCT) and improvement in the American College of Rheumatology Combined Response Index in Diffuse SSc (ACR-CRISS) score.

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