Corbus Pharmaceuticals changes primary endpoint in RESOLVE-1 trial to ACR CRISS
Corbus Pharmaceuticals announced that following a Type C meeting with the FDA, Corbus will change the primary efficacy endpoint of the ongoing RESOLVE-1 Phase 3 trial for systemic sclerosis, or SSc, in the U.S. to the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis, or ACR CRISS, score at Week 52 from the current primary endpoint, change in modified Rodnan Skin core, or mRSS. The ACR CRISS score was the primary efficacy endpoint of the Phase 2 study evaluating lenabasum for the treatment of diffuse cutaneous SSc. The company remains on track to complete the RESOLVE-1 study in the first half of 2020 and no changes to the size or length of the study are required. The ACR CRISS score provides a measure of response to treatment compared to mRSS, which only measures skin thickening. The ACR CRISS score is calculated from weighted changes from baseline in five core outcome measures commonly used to evaluate treatment effect in trials for SSc.