02 Nov `23Efficacy and Safety of Ruxolitinib Cream in Adolescent Patients With Vitiligo (STOP-V2)

This Phase 3 study, sponsored by Incyte Corporation, aims to evaluate the efficacy and safety of ruxolitinib cream in treating vitiligo in patients aged 12 to 17 years.

Key Details

- Study Type: Interventional (Clinical Trial)
- Phase: Phase 3
- Estimated Enrollment: 60 participants
- Age Range: 12 to 17 years
- Duration: 52 weeks

The trial will compare ruxolitinib cream to a vehicle cream (placebo) in adolescents with non-segmental vitiligo. Participants will be randomly assigned to receive either ruxolitinib cream or the vehicle cream, applied twice daily to affected areas for 24 weeks. After this initial period, all participants will receive ruxolitinib cream for an additional 28 weeks.

Primary Outcome Measure

The primary outcome measure is the proportion of participants achieving ≥75% improvement from baseline in facial Vitiligo Area Scoring Index (F-VASI75) at Week 24.

This study is currently recruiting participants at multiple locations across the United States. It represents an important step in expanding treatment options for younger patients with vitiligo and could potentially lead to a new FDA-approved therapy for this age group.

Inclusion Criteria

1.Male or female participants aged 12 to 17 years at the time of signing informed consent
2.Diagnosis of non-segmental vitiligo
3.Total body surface area (BSA) of vitiligo lesions ≤20%
4.F-VASI total score ≥0.5 points at screening and baseline
5.Willing and able to comply with study restrictions and requirements

Exclusion Criteria

1.History of other skin conditions that could interfere with evaluations
2.Use of certain medications or treatments within specified timeframes before the first dose of study drug
3.Known hypersensitivity to ruxolitinib or its excipients
4.Pregnant or breastfeeding females
5.Participation in other investigational drug studies within 30 days

For more information about eligibility criteria and study locations, please visit the official clinical trial page on ClinicalTrials.gov (NCT06113471) or contact the study team directly.

The VRF will continue to monitor the progress of this trial and provide updates as they become available. We encourage eligible individuals to consider participating in this important research effort to advance vitiligo treatment.