A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis

Abstract

A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI-4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end-point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end-point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02-28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

Keywords: BBI-4000; Hyperhidrosis Disease Severity Score; phase 3 study; primary axillary hyperhidrosis; sofpironium bromide gel.

Figure 1

Patient disposition. FAS, full analysis set; PPS, per protocol set; SAF, safety analysis set.

Figure 2

Changes in values of secondary efficacy end‐points at each evaluation point. (a) Changes in proportion of patients with Hyperhidrosis Disease Severity Score (HDSS) of 1, 2, 3 or 4. (b) Changes in total gravimetric weight of sweat. (c) Changes in Hyperhidrosis Disease Severity Measure–Axillary (HDSM‐Ax) score. Data from each patient at baseline and week 6 consisted of the median of measurements at three time points each (baseline‐1 to ‐3 and week 6‐1 to ‐3, respectively), and data from each patient at weeks 2 and 4 consisted of the measurement at one time point each. The patients with no data at each evaluation point were excluded from the analysis.