Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up

This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV). The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9–45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesion counts. Three hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error SE) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: – 24.3 (0.7) vs. – 15.4 (1.0) (p < 0.001) and – 73.2% vs. – 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 51.1%) responded well to a second 12W course of sarecycline with a mean (standard deviation SD) reduction of – 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts. Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population. Chinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .