Table 1.
Analysis of Primary Endpoint: Change From Baseline to Week 13 in ItchRO(Obs)
| Change From Baseline | Treatment Compared to Placebo | |||||||
|---|---|---|---|---|---|---|---|---|
|
Outcome Measure Treatment Group Maralixibat |
n | Baseline Mean (SEM) | LS Means Change (SEM) | 95% CI | P value | Difference in LS Means (SEM) | 95% CI | P value |
| ItchRO(Obs) average daily score | ||||||||
| 70 μg/kg/day | 8 | 3.2 (0.23) | –1.5 (0.30) | (–2.1, –0.9) | <.001 | –0.89 (0.40) | (–1.70, –0.08) | 0.032 |
| 140 μg/kg/day | 11 | 2.7 (0.16) | –1.5 (0.26) | (–2.0, –1.0) | <.001 | –0.91 (0.35) | (–1.62, –0.19) | 0.014 |
| 280 μg/kg/day | 6 | 3.3 (0.24) | –0.6 (0.36) | (–1.3, 0.1) | 0.093 | –0.04 (0.44) | (–0.94, 0.86) | 0.930 |
| Maralixibat* | 17 | 2.9 (0.15) | –1.1 (0.21) | (–1.5, –0.6) | <.001 | –0.47 (0.33) | (–1.14, 0.20) | 0.159 |
| Maralixibata | 25 | 3.0 (0.13) | –1.2 (0.18) | (–1.6, –0.8) | <.001 | –0.61 (0.31) | (–1.24, 0.01) | 0.055 |
| Placebo | 12 | 2.8 (0.15) | –0.6 (0.25) | (–1.1, –0.1) | 0.024 | |||
Abbreviation: LS, least squares.