A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

Conditions

Vitiligo

Brief summary

Proportion of participants achieving F-VASI75 at Week 24

Detailed description

Proportion of participants achieving F-VASI50 at Week 24, Proportion of participants achieving F-VASI90 at Week 24, Proportion of participants achieving T-VASI50 at Week 24, Percentage change from baseline in F-BSA at Week 24, AEs, assessed by changes in vital signs, clinical evaluations, height, weight, and laboratory data, Proportion of participants achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Weeks 24 and 52, Proportion of participants in each category for the color-matching question at Weeks 24 and 52, Proportion of participants who report F-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Proportion of participants who report T-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Change from baseline in VIT-PIQ at Weeks 24 and 52, Change from baseline in CDLQI at Weeks 24 and 52, Change from baseline in PGIB-V at Weeks 24 and 52, Mean satisfaction score at Weeks 24 and 52, Preapplication plasma concentrations of ruxolitinib at Weeks 4, 24, 40, and 52

Related papers

No related papers found yet.

Interventions

DRUGRuxolitinib (INCB018424) cream

DRUGVehicle (placebo) cream

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving F-VASI75 at Week 24	—

Secondary

Measure	Time frame
Proportion of participants achieving F-VASI50 at Week 24, Proportion of participants achieving F-VASI90 at Week 24, Proportion of participants achieving T-VASI50 at Week 24, Percentage change from baseline in F-BSA at Week 24, AEs, assessed by changes in vital signs, clinical evaluations, height, weight, and laboratory data, Proportion of participants achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Weeks 24 and 52, Proportion of participants in each category for the color-matching question at Weeks 24 and 52, Proportion of participants who report F-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Proportion of participants who report T-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Change from baseline in VIT-PIQ at Weeks 24 and 52, Change from baseline in CDLQI at Weeks 24 and 52, Change from baseline in PGIB-V at Weeks 24 and 52, Mean satisfaction score at Weeks 24 and 52, Preapplication plasma concentrations of	—

Measure

Time frame

Proportion of participants achieving F-VASI50 at Week 24, Proportion of participants achieving F-VASI90 at Week 24, Proportion of participants achieving T-VASI50 at Week 24, Percentage change from baseline in F-BSA at Week 24, AEs, assessed by changes in vital signs, clinical evaluations, height, weight, and laboratory data, Proportion of participants achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Weeks 24 and 52, Proportion of participants in each category for the color-matching question at Weeks 24 and 52, Proportion of participants who report F-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Proportion of participants who report T-PaGIC-V of very much improved or much improved at Weeks 24 and 52, Change from baseline in VIT-PIQ at Weeks 24 and 52, Change from baseline in CDLQI at Weeks 24 and 52, Change from baseline in PGIB-V at Weeks 24 and 52, Mean satisfaction score at Weeks 24 and 52, Preapplication plasma concentrations of

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Countries

Austria, Belgium, Bulgaria, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed