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

NCT ID: NCT05247489

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2023-12-19

Brief 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).

Conditions

Vitiligo

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Ruxolitinib 1.5% cream

Intervention Type: DRUG

Ruxolitinib cream 1.5% applied twice a day (BID).

NB-UVB phototherapy

Intervention Type: DEVICE

NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit

Group B: Ruxolitinib Monotherapy

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.

Group Type: EXPERIMENTAL

Ruxolitinib 1.5% cream

Intervention Type: DRUG

Ruxolitinib cream 1.5% applied twice a day (BID).

Interventions

Ruxolitinib 1.5% cream

Ruxolitinib cream 1.5% applied twice a day (BID).

Intervention Type: DRUG

NB-UVB phototherapy

NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit

Intervention Type: DEVICE

Other Intervention Names

Narrow-Band Ultraviolet B Phototherapy

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haq Nawaz, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

First Oc Dermatology

Fountain Valley, California, United States

UC Davis Health

Sacramento, California, United States

Palo Alto Medical Foundation

Sunnyvale, California, United States

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

Baton Rouge, Louisiana, United States

Aesthetic and Dermatology Center

Rockville, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Metro Boston Clinical Partners

Brighton, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, United States

Principle Research Solutions

Spokane, Washington, United States

Simcomed Health Ltd

Barrie, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 18424-217

Identifier Type: -

Identifier Source: org_study_id