Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants with Cholestatic Pruritus

Conditions

Cholestatic Pruritus

Brief summary

Mean change in the average worst Observer-rated Itch-Reported Outcome (ItchRO[Obs]) severity score from baseline through Weeks 13–20. The baseline average worst ItchRO(Obs) score is defined as the 2-week average worst ItchRO(Obs) severity score prior to the first dose of the study drug, where the worst ItchRO(Obs) severity score is defined as the higher of the morning severity score and evening severity score.

Detailed description

Change from baseline to average of Week 12 and Week 20 in total sBA, Percentage of days through Weeks 13–20 with pruritus improvement (worst ItchRO(Obs) score <1 or decrease from baseline of ≥1), Proportion of participants with ≥50% reduction from baseline to average of Week 12 and Week 20 in sBA levels, Mean change in the average worst ItchRO(Pt) severity score from baseline through Weeks 13–20. The baseline average worst ItchRO(Pt) score is defined as the 2-week average worst ItchRO(Pt) severity score prior to the first dose of the study drug.

Related papers

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Interventions

DRUGMaralixibat chloride

DRUGPlacebo

DRUGoral solution

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Change from baseline to average of Week 12 and Week 20 in total sBA, Percentage of days through Weeks 13–20 with pruritus improvement (worst ItchRO(Obs) score <1 or decrease from baseline of ≥1), Proportion of participants with ≥50% reduction from baseline to average of Week 12 and Week 20 in sBA levels, Mean change in the average worst ItchRO(Pt) severity score from baseline through Weeks 13–20. The baseline average worst ItchRO(Pt) score is defined as the 2-week average worst ItchRO(Pt) severity score prior to the first dose of the study drug.	—

Measure

Time frame

Change from baseline to average of Week 12 and Week 20 in total sBA, Percentage of days through Weeks 13–20 with pruritus improvement (worst ItchRO(Obs) score <1 or decrease from baseline of ≥1), Proportion of participants with ≥50% reduction from baseline to average of Week 12 and Week 20 in sBA levels, Mean change in the average worst ItchRO(Pt) severity score from baseline through Weeks 13–20. The baseline average worst ItchRO(Pt) score is defined as the 2-week average worst ItchRO(Pt) severity score prior to the first dose of the study drug.

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Primary

Measure	Time frame
Mean change in the average worst Observer-rated Itch-Reported Outcome (ItchRO[Obs]) severity score from baseline through Weeks 13–20. The baseline average worst ItchRO(Obs) score is defined as the 2-week average worst ItchRO(Obs) severity score prior to the first dose of the study drug, where the worst ItchRO(Obs) severity score is defined as the higher of the morning severity score and evening severity score.	—