THWART-2 is one of two randomized double-blind vehicle-controlled Phase 3 pivotal trials conducted by Aclaris to evaluate A-101 45% Topical Solution as a potential treatment for common warts. Aclaris expects to report data from THWART-1 (WART-301), the second Phase 3 trial during the fourth quarter of 2019. Both trials evaluated the efficacy and safety of A-101 45% Topical Solution as compared to placebo (vehicle). The two randomized, double-blind, vehicle-controlled trials were designed to demonstrate the efficacy and safety of A-101 45% Topical Solution for the potential treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).
In the THWART-2 trial, 502 subjects who had one to six warts at baseline were randomized and self-administered either A-101 45% Topical Solution or vehicle twice a week over 8 weeks, for a total of 16 treatments. The trial achieved its primary endpoint with a high degree of statistical significance (p<0.0001), i.e. a higher proportion of subjects treated in the A-101 45% Topical Solution arm versus vehicle had all their identified common warts reported as clear at Day 60. Warts were assessed using the Physician Wart Assessment scale (PWA=0) which is a validated four-point scale of the investigators’ assessment of the severity of all treated warts.
In the trial, all secondary efficacy endpoints achieved statistical significance in favor of A-101 45% Topical Solution versus vehicle and are described as follows:
- Complete clearance of all warts at Day 137 (12 weeks after last treatment) (p=0.0001)
- Mean per subject percent of treated warts cleared at Day 137 (p<0.0001)
- Clearance in subjects with a single baseline wart at Day 60 (p=0.0006)
- Time to complete clearance of all warts (p<0.0001)
There were no treatment-related serious adverse events (SAEs) in subjects treated with A-101 45% Topical Solution; however, SAEs of intestinal obstruction (in the A-101 45% Topical Solution group) and staghorn renal calculus (vehicle group) were assessed by the investigators as unrelated. Treatment-related application site adverse events (AEs) were reported in 53.4% and 8.4% of the A-101 45% Topical Solution and vehicle groups respectively. In the active arm 2% (5 subjects) of application site events were severe (1 pain, and 4 site pallor). The most common AEs (occurring in more than 5% of subjects) were application site pain, pallor, erythema, pruritus, scabbing and erosion. No subjects withdrew because of AEs.
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