NonSegmental Vitiligo
Conditions
Keywords
NonSegmental Vitiligo, pediatric
Brief summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Interventions
DRUGRuxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
DRUGVehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 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.
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). * 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. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition. * Protocol-defined clinically significant abnormal laboratory values at screening. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation. * In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study. * Employees of the sponsor or investigator or are otherwise dependents of them. * Known allergy or reaction to any component of the study cream formulation. Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) | Week 24 | ≥75% improvement in facial Vitiligo Area Scoring Index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | Week 24 | ≥50% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) | Week 24 | ≥90% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) | Week 24 | ≥50% improvement in total body Vitiligo Area Scoring Index. |
| Percentage change from baseline in F-BSA | Week 24 | Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area. |
| Number of Treatment Emergent Adverse Events (TEAEs) | Up to Week 52 and 30 days | TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) | Week 52 | ≥75% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) | Week 52 | ≥50% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25) | Week 24 and Week 52 | ≥25% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) | Week 24 and Week 52 | ≥75% improvement in total body Vitiligo Area Scoring Index |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) | Week 24 and Week 52 | ≥90% improvement in total body Vitiligo Area Scoring Index |
| Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations | Weeks 6, 24, 30 and 52 | Trough is defined as the concentration reached by a drug immediately before the next dose is administered. |
Countries
Canada, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed