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
Corbus Pharmaceuticals Holdings, Inc. (CRBP)
Last corbus pharmaceuticals holdings, inc. earnings: 3/12 07:05 am
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Source: GlobeNewswire
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 2020 Norwood, 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 t
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CRBP
Sec Filings
- 4/11/24 - Form 4
- 4/10/24 - Form DEFA14A
- 4/10/24 - Form 8-K
- CRBP's page on the SEC website