Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Interventional
Phase 3
Incyte Corporation (Voir sur ClinicalTrials)
novembre 2025
décembre 2027
17 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | KHALED EZZEDINE | 17/12/2025 12:05:32 | Contacter | ||
Critères
Tous
- 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.