Dermavant is developing the treatments dermatologists want and for which their patients have been waiting. The company’s medical dermatology pipeline includes commercialized, late-stage, and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets — plaque psoriasis and atopic dermatitis — as well as other immunological and inflammatory diseases.
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PSOARING is Dermavant’s pivotal Phase 3 plaque psoriasis clinical program for tapinarof, which consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.
PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. The PSOARING clinical program was completed on April 5, 2021.
ADORING is Dermavant’s pivotal Phase 3 atopic dermatitis (AD) clinical program for tapinarof, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3, a long-term extension study.
ADORING 1 and ADORING 2 are two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies being conducted in North America. The Phase 3 clinical program will enroll up to 800 patients across the two pivotal trials to evaluate the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 8 weeks versus vehicle cream QD in patients aged 2 years and older diagnosed with moderate to severe AD. ADORING 3 is an open-label, long-term extension study to evaluate the safety and efficacy of tapinarof cream, 1% in patients with AD. Patients in the study will include those who previously completed ADORING 1, ADORING 2, or a Maximal Use Pharmacokinetics study. In addition, approximately 125 pediatric patients will directly enroll into the study. ADORING 3 will consist of up to 48 weeks of tapinarof cream, 1%, and a 7-day safety follow-up period.