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

Launched by INCYTE CORPORATION · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new cream called ruxolitinib to see if it is safe and effective for children with nonsegmental vitiligo, a condition where patches of skin lose their color. The trial is currently looking for participants aged between 2 and 17 years who have certain characteristics of vitiligo, such as noticeable light patches on their skin. To qualify, children should have some areas of their skin that have lost color but not more than 10% of their entire body. Participants will need to stop using any other treatments for vitiligo during the study.

If your child is eligible and chooses to participate, they will apply the cream as directed and attend regular follow-up visits to monitor their progress and any side effects. It's important to note that participants must agree to avoid getting pregnant or fathering a child during the study. This trial offers an opportunity to help researchers understand how well this new treatment works for young people with vitiligo, potentially leading to better options for managing this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.
• • Current or previous use of JAK inhibitors, systemic or topical.
• • 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.
• • Other protocol-defined Inclusion/Exclusion Criteria may apply.