Clinical Data
The 127-subject multi-center, randomized, placebo-controlled, trial evaluated treatment with once-daily, orally administered serlopitant 5 mg tablets compared with placebo for 8 weeks. The trial was conducted at 15 clinical study sites in Germany. All enrolled subjects had severe pruritus as determined by a visual analog scale (VAS) pruritus score ≥7 on a 0-10 scale at screening.Results of the trial demonstrated that serlopitant 5 mg provided a statistically significant greater reduction of pruritus in the serlopitant-treated group compared with the placebo group. At 8 weeks, the serlopitant-treated group reported a 48% reduction in average pruritus severity as compared with a 26% reduction in the placebo-treated group. A statistically significant greater reduction of pruritus in the serlopitant 5 mg group compared with control was observed at every evaluation timepoint (weeks 2, 4, and 8) on the primary measure of pruritus in the study. Multiple additional measures of itch in this study confirmed the findings of reduced pruritus in serlopitant-treated subjects vs the placebo group.