Estudio de eficacia y seguridad de fase 3, aleatorizado, ... | EligiMed

Estudio de eficacia y seguridad de fase 3, aleatorizado, doble ciego, de crema de ruxolitinib en niños (de 6 a < 12 años) con vitíligo no segmentario

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06804811Tipo: INTERVENTIONALInicio: 13 de nov de 2025Fin estimado: 1 de dic de 2027

Resumen

El propósito de este estudio es evaluar la eficacia y seguridad de la crema de ruxolitinib en niños (de 6 a < 12 años) con vitíligo no segmentario.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 11 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Ruxolitinib Cream

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

drug

Vehicle Cream

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Ubicaciones

Psoriahue

Buenos Aires, Argentina

NOT_YET_RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

NOT_YET_RECRUITING

Instituto de Neumonologia Y Dermatologia

Buenos Aires, Argentina

NOT_YET_RECRUITING

Consultorios Medicos Dr. Doreski

Buenos Aires, Argentina

NOT_YET_RECRUITING

Derma Internacional S.A.

Buenos Aires, Argentina

NOT_YET_RECRUITING

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

NOT_YET_RECRUITING

Hospital Universitario Austral

Pilar, Argentina

NOT_YET_RECRUITING

Hospital Del Nino Jesus

San Miguel de Tucumán, Argentina

NOT_YET_RECRUITING

Patrocinadores

PrincipalIncyte Corporation

Contactos

Incyte Corporation Call Center (US)

CONTACT

medinfo@incyte.com 1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

eumedinfo@incyte.com +800 00027423

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