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

Vitiligo Clinical Trial

Official title:

A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05247489
• Other study ID #: INCB 18424-217
• Status: Completed
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: February 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

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

Device:
• 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

Locations

Country	Name	City	State
Canada	Simcomed Health Ltd	Barrie	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
United States	Delricht Clinical Research - Clinedge - Ppds Baton Rouge	Baton Rouge	Louisiana
United States	Tufts Medical Center	Boston	Massachusetts
United States	Metro Boston Clinical Partners	Brighton	Massachusetts
United States	Henry Ford Medical Center - New Center One	Detroit	Michigan
United States	First Oc Dermatology	Fountain Valley	California
United States	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas
United States	Aesthetic and Dermatology Center	Rockville	Maryland
United States	UC Davis Health	Sacramento	California
United States	Principle Research Solutions	Spokane	Washington
United States	Palo Alto Medical Foundation	Sunnyvale	California
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in T-VASI	T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.	Week 48
Secondary	Number of treatment-related adverse events	Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.	Approximately 14 months
Secondary	Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit	Defined as = 50/75/90% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score. Facial VASI is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit	Defined as = 50/75/90% improvement from baseline in Total Body Vitiligo Area Scoring Index (T-VASI) score. T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Percentage change from baseline in F-VASI at each post-baseline visit	Face Vitiligo Area Scoring Index (F-VASI) score is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Percentage change from baseline in T-VASI at each post-baseline visit	T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Percentage change from baseline in F-BSA at each post-baseline visit	Facial BSA (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Percentage change from baseline in T-BSA at each post-baseline visit	Total BSA (T-BSA) takes into account the depigmented areas for each of the following body regions: head/neck (including scalp), upper extremities (including axillae), hands, trunk (including genitalia), lower extremities (including buttocks), and feet. Body surface area assessment will be performed by the Palmar Method.	Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary	Population-based (trough) plasma concentrations of ruxolitinib	Trough is defined as the concentration reached by a drug immediately before the next dose is administered.	Weeks 4, 12, and 16