Patient-reported outcomes
sleep disturbance, itch
Mean visual analog scale (VAS) itch at baseline was 1.1, 0.5, 0.7 and 0.6 for tropifexor 10, 30, 60 and 90 μg, respectively, versus 0.4 in the placebo group (Parts A + B), and 1.1 and 0.7 for tropifexor 140 and 200 μg, respectively, versus 0.9 in the placebo group (Part C). No notable differences in LS mean worsening in VAS for itch from baseline to weeks 6 or 12 were noted in the placebo or tropifexor 10–90-μg groups. Although the LS mean worsening in VAS for itch from baseline was notably greater for the tropifexor 140- and 200-μg groups versus placebo at weeks 6 (1.0 and 1.0 versus −0.1; The impact on VAS for sleep disturbance due to itch was comparable between the placebo and tropifexor 10–200-μg groups up to end-of-treatment. The LS mean worsening from baseline was 0.3 and 0.5 versus 0.1 in the tropifexor 140- (