Dermavant: First Patient Dosed in Phase 3 Study of Tapinarof in AD

The first patient has been dosed in the Phase 3, double-blind, vehicle-controlled pivotal study of tapinarof for the treatment of atopic dermatitis (AD). Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development by Dermavant as a once-daily, steroid-free topical cream for the treatment of plaque psoriasis and atopic dermatitis.

“Atopic dermatitis remains an area of unmet medical need, particularly in children. As such, we are pleased to report the first patient dosed in our Phase 3 ADORING study, as we investigate the role tapinarof may have on advancing treatment for patients as young as 2 years-old with AD,” says Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. “We are excited about the potential of tapinarof and are eager to progress these studies.”

Dermavant’s pivotal Phase 3 clinical program for tapinarof in atopic dermatitis (AD) will consist of two identical pivotal trials (ADORING 1 and ADORING 2) followed by an open-label, long-term extension study (ADORING 3).

ADORING 1 and ADORING 2 are two identical, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies that will be 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. The primary endpoint of both studies will be the percentage of patients achieving a vIGA-AD™ (Validated Investigator Global Assessment for Atopic Dermatitis) of 0 or 1 with at least a 2-grade improvement from baseline at week 8.

ADORING 3 is a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% in patients with AD. Subjects in the study will include those who have previously completed treatment with tapinarof or vehicle in Phase 3 studies. ADORING 3 will consist of up to 48 weeks of tapinarof cream, 1%, and a 7-day safety follow-up period.