A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Incyte Corporation98 sites in 1 country180 target enrollmentJanuary 24, 2025

Overview

Phase: Phase 3
Intervention: Ruxolitinib Cream
Conditions: NonSegmental Vitiligo
Sponsor: Incyte Corporation
Enrollment: 180
Locations: 98
Primary Endpoint: Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Status: Recruiting
Last Updated: 4 months ago

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Registry

clinicaltrials.gov

Start Date

January 24, 2025

End Date

March 13, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI.
•Total body vitiligo area does not exceed 10% BSA.
•Pigmented hair within some of the areas of vitiligo on the face.
•Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
•For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.

•Diagnosis of other forms of vitiligo (eg, segmental).
•Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
•Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
•Prior or current use of depigmentation treatments (eg, monobenzone).
•Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
•Use of protocol-defined treatments within the indicated washout period before baseline.
•Current or previous use of JAK inhibitors, systemic or topical.
•Protocol-defined clinically significant abnormal laboratory values at screening.
•BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
•Pregnant or lactating participants or those considering pregnancy during the period of their study participation.

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Intervention: Ruxolitinib Cream

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Intervention: Vehicle Cream

Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)

Time Frame: Week 24

≥75% improvement in facial Vitiligo Area Scoring Index.

Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)(Week 52)
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)(Week 52)
Percentage change from baseline in F-BSA(Week 24)
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)(Week 24 and Week 52)
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations(Weeks 6, 24, 30 and 52)
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 24)
Number of Treatment Emergent Adverse Events (TEAEs)(Up to Week 52 and 30 days)
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)(Week 24 and Week 52)
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)(Week 24 and Week 52)
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)(Week 52)
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 52)