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

• Status: Not yet recruiting
• Trial end date: 2024-01-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:

1. ≥ 0.5 F-VASI on the face

2. ≥ 3.0 T-VASI (body areas not including the face)

3. Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.

• Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

• No pigmented hair within any of the vitiligo areas on the face.

• Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.

• Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.

• Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.

• Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.

• History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).

• Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.

• Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.

• Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.

• Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.

• Specific protocol-defined chemistry, hematology, and serological lab values.

• Those who are pregnant, lactating or considering pregnancy during the period of study participation.