301 Tapinarof cream 1% once daily for the treatment of extensive atopic dermatitis in adolescents and children: 4-week maximal use trial

Abstract

Abstract There is a need for efficacious non-steroidal topical therapies for atopic dermatitis (AD) without restrictions relating to duration, the extent of use and application sites. Tapinarof (VTAMA®; Dermavant Sciences, Inc., USA) is a first-in-class, non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the Food and Drug Administration for the treatment of plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age and for AD in adults and children down to 2 years of age. Tapinarof cream 1% once daily (QD) demonstrated significant efficacy vs. vehicle at 12 weeks and was well tolerated in adults and adolescents and with moderate to severe AD in a previously reported phase 2b trial (NCT02564055). To assess the safety, tolerability, pharmacokinetics (PK) and efficacy of tapinarof cream 1% QD in adolescents and children with extensive AD. In this open-label, maximal use, phase 2 trial (NCT05186805), adolescents and children, aged 2–17 years, with a clinical diagnosis of AD, a validated Investigator Global Assessment in Atopic Dermatitis™ (vIGA-AD™) score ≥3, and percent body surface area (%BSA) involvement of ≥ 25% for adolescents (12–17 years) or ≥35% for children (2–11 years) were assigned tapinarof cream 1% QD for 27 days. Primary endpoints include adverse events, mean investigator-assessed local tolerability scores (overall and sensitive areas) and PK parameters. Secondary endpoints include a change in vIGA-AD™, Eczema Area Severity Index (EASI), %BSA affected, and Peak Pruritus-Numeric Rating Scale scores at each trial visit. Eligible patients completing this trial have the option to enrol in an open-label, long-term extension trial (NCT05142774) to receive up to an additional 48 weeks of tapinarof cream 1% QD treatment. Overall, 36 patients aged 2–17 years were enrolled at nine sites in the US and Canada. Of these patients, equal proportions (33.3% [12/36]) were young children (2–6 years), children (7–11 years) and adolescents (12–17 years); 66.7% (24/36) were male and mean age (standard deviation [SD]) was 8.9 (4.9) years. At baseline, 77.8% (28/36) had a vIGA-AD™ score of 3 (moderate) and 8/36 (22.2%) had a score of 4 (severe). At baseline, the mean (SD) %BSA affected was 52.4% (19.1%), 42.0% (10.0%) and 33.9% (8.6%) for young children, children and adolescents, respectively. The overall mean (SD) EASI score was 23.8 (9.2). This trial will assess the safety, tolerability, PK and efficacy of tapinarof cream 1% QD in 36 adolescents and children down to 2 years of age with extensive, moderate-to-severe AD.