A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Ki vehet részt

• 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

Ki nem vehet részt

• Prior or current use of depigmentation treatments (eg, monobenzone)
• Use of protocol-defined treatments within the indicated washout period before baseline
• 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
• 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
• 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
• Known allergy or reaction to any component of the study cream formulation; Other protocol-defined Inclusion/Exclusion Criteria may apply
• Protocol-defined clinically significant abnormal laboratory values at screening
• Diagnosis of other forms of vitiligo (eg, segmental)
• 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