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

Incyte

Status and phase: Completed; Phase 2

Conditions: Vitiligo

Treatments: Device: NB-UVB phototherapy; Drug: Ruxolitinib 1.5% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05247489

INCB 18424-217

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)

Experimental group

Description:

Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.

Treatment:

Drug: Ruxolitinib 1.5% cream

Device: NB-UVB phototherapy

Group B: Ruxolitinib Monotherapy

Experimental group

Description:

Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.

Treatment:

Drug: Ruxolitinib 1.5% cream