Vitiligo
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Incyte Study ID:
INCB18424-312
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jan 2025 - Aug 2026
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
2 - 11 Years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
CENTRE DE RECHERCHE SAINT-LOUIS
QUEBEC CITY, QC, Canada, G1W 4R4
Status
Not yet recruiting
Name
UNIVERSITY OF TORONTO - THE HOSPITAL FOR SICK CHILDREN (SICKKIDS)
TORONTO, ON, Canada, M5G1X8
Status
Not yet recruiting
Name
RESEARCH TORONTO
TORONTO, ON, Canada, M4W 2N4
Status
Recruiting
Name
SKINCARE STUDIO DERMATOLOGY CENTRE
ST. JOHN'S, Canada, A1E 1V4
Status
Not yet recruiting
Name
ALBERTA DERMASURGERY CENTRE
EDMONTON, AB, Canada, T6G 1C3
Status
Not yet recruiting
Name
KIRK BARBER RESEARCH
CALGARY, AB, Canada, T2G 1B1
Status
Not yet recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Protocol Summary
Incyte Study ID:
INCB18424-312
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Interventions:
Drug
Enrollment:
180
Primary Outcome
Open
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
Timeframe: Week 24
Secondary Outcome
Open
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Timeframe: Week 24
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Timeframe: Week 24
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
Timeframe: Week 24
Percentage change from baseline in F-BSA
Timeframe: Week 24
Number of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 52 and 30 days
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
Timeframe: Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)
Timeframe: Week 52
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
Timeframe: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)
Timeframe: Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)
Timeframe: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)
Timeframe: Week 24 and Week 52
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)
Timeframe: Week 24 and Week 52
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations
Timeframe: Weeks 6, 24, 30 and 52