Brickell BioTech, Inc announced the completion of its Cardigan I study and final enrollment of the Cardigan II study.
Brickell BioTech Inc. announced the final patient has completed its phase 3 pivotal Cardigan I (NCT03836287) study and all patients were enrolled into the phase 3 pivotal Cardigan II (NCT03948646) study.1 Both trials are evaluating the safety and efficacy of sofpironium bromide gel 15% as treatment for underarm hyperhidrosis.
Each of these multicenter, randomized, double-blinded, placebo-controlled studies enrolled 350 patients 9 years and older diagnosed with primary axillary hyperhidrosis. In the studies, patients apply sofpironium bromide gel 15% or placebo to their underarms daily at bedtime for 6 weeks and are then assessed at a 2-week post-treatment follow-up.
The co-primary efficacy endpoints of both studies were the proportion of subjects achieving a 2-point or greater improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, a patient-reported outcome measure, and the change in baseline to end of treatment in the gravimetric sweat production (GSP).
Results from the Cardigan I and Cardigan 2 clinical studies are expected to be announced in the final quarter of 2021, and if successful, Brickell Biotech expects to form the basis for a future New Drug Application (NDA) in the U.S.
“This is truly an exciting time for the Brickell team, as we have now completed enrollment in both of our phase 3 pivotal clinical studies of sofpironium bromide gel, 15%. Also, since completing enrollment in the Cardigan I study in April, the last hyperhidrosis patient enrolled has completed the study,” said Deepak Chadha, chief research and development officer of Brickell, Boulder, Colorado. “On behalf of Brickell, I want to take this opportunity to thank the patients and investigators who participated in the Cardigan I study, as well as those currently participating in the Cardigan II study. We remain focused on completing the Cardigan II study as planned and reporting topline results from the phase 3 program in the fourth quarter of 2021. We look forward to sharing updates on the progress of the phase 3 pivotal clinical studies over the coming months.”
1. Biotech B. Brickell biotech completes patient enrollment in u. S. Phase 3 pivotal cardigan i study of sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. GlobeNewswire News Room. Published April 27, 2021. Accessed July 8, 2021. https://www.globenewswire.com/news-release/2021/04/27/2217558/0/en/Brickell-Biotech-Completes-Patient-Enrollment-in-U-S-Phase-3-Pivotal-Cardigan-I-Study-of-Sofpironium-Bromide-Gel-15-for-the-Treatment-of-Primary-Axillary-Hyperhidrosis.html