A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

Incyte

Status and phase: Enrolling; Phase 3

Conditions: NonSegmental Vitiligo

Treatments: Drug: Vehicle Cream; Drug: Ruxolitinib Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT06804811

2024-513171-41-00 (Registry Identifier)

INCB18424-309

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to < 12 years old) with nonsegmental vitiligo.

Enrollment: 250 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 6 to < 12 years at the time of signing the ICF.
• 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 as defined in the protocol.

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).
• Concurrent conditions and history of protocol-defined diseases
• 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 for vitiligo or any other inflammatory condition.
• 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.
• 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.
• The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health code.
• In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 3 patient groups, including a placebo group

Ruxolitinib 0.75 % Cream

Experimental group

Description:

Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.

Treatment:

Drug: Ruxolitinib Cream

Ruxolitinib 1.5 % Cream

Experimental group

Description:

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

Treatment:

Drug: Ruxolitinib Cream

Vehicle Cream

Placebo Comparator group

Description:

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

Treatment:

Drug: Vehicle Cream