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Corbus Pharmaceuticals Announces Change of Primary Endpoint in Ongoing RESOLVE-1 Phase 3 Study in Systemic Sclerosis in U.S. to ACR CRISS from mRSS Following Meeting with FDA
Phase 3 primary endpoint will now be aligned with that of previous Phase 2 studyACR CRISS is a composite index (composed of multiple outcomes including mRSS)
About this update from Corbus Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"Phase 3 primary endpoint will now be aligned with that of previous Phase 2 studyACR CRISS is a composite index (composed of multiple outcomes including mRSS) and was secondary endpoint in current Phase 3 study Change in mRSS will become secondary endpoint No changes to conduct or size of Phase 3 study; study remains on track for completion in the first half of 2020Norwood, MA, April 18, 2019 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) (\"Corbus\" or the \"Company\") today announced that following a Type C meeting with the U.S. Food and Drug Administration (FDA), Corbus will change the primary efficacy endpoint of the ongoing RESOLVE-1 Phase 3 trial for systemic sclerosis (SSc) in the U.S. to the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis (ACR CRISS) score at Week 52 from the current primary endpoint, change in modified Rodnan Skin core (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 comprehensive 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: mRSS, Health Assessment Questionnaire - Disability Index (HAQ-DI), forced vital capacity (FVC) percent predicted, and patient and physician global assessments of health related to SSc.\"Following a recent Type C meeting with the FDA, we will be designating the ACR CRISS score as the primary efficacy endpoint for the current RESOLVE-1 Phase 3 study in the U.S. In that meeting, the FDA recognized the unmet medical needs of SSc patients, challenges in developing drugs to treat SSc and limitations of current endpoints for trials in SSc. The FDA deferred selection of the primary efficacy endpoint to Corbus. The FDA stated that the components of ACR CRISS reflect relevant aspects of SSc, and they will consider the totality of the data during review of any marketing application in SSc. We will pursue discussions with other regulatory authorit...