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

Sponsor

Incyte Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05247489

Collaborator

(none)

Enrollment

Locations

Arms

21.8

Anticipated Duration (Months)

3.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vitiligo JAK Inhibitor	Drug: Ruxolitinib 1.5% cream Device: NB-UVB phototherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 5, 2022

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Feb 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Other Names: Narrow-Band Ultraviolet B Phototherapy
Experimental: 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.	Drug: Ruxolitinib 1.5% cream Ruxolitinib cream 1.5% applied twice a day (BID).

Arm

Intervention/Treatment

Experimental: 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.

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

Other Names:

Narrow-Band Ultraviolet B Phototherapy

Experimental: 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.

Drug: Ruxolitinib 1.5% cream

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

Outcome Measures

Primary Outcome Measures

Change from Baseline in T-VASI [Week 48]
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.

Secondary Outcome Measures

Number of treatment-related adverse events [Approximately 14 months]
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Percentage of participants achieving F-VASI50/75/90 at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
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.
Percentage of participants achieving T-VASI50/75/90 at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
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.
Percentage change from baseline in F-VASI at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
Face Vitiligo Area Scoring Index (F-VASI) score is measured by percentage of vitiligo involvement (%BSA) and the degree of depigmentation.
Percentage change from baseline in T-VASI at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
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.
Percentage change from baseline in F-BSA at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
Facial BSA (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Percentage change from baseline in T-BSA at each post-baseline visit [Weeks 4, 8, 12, 16, 24, 32, 40 and 48]
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.
Population-based (trough) plasma concentrations of ruxolitinib [Weeks 4, 12, and 16]
Trough is defined as the concentration reached by a drug immediately before the next dose is administered.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

≥ 0.5 F-VASI on the face
≥ 3.0 T-VASI (body areas not including the face)
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Oc Dermatology	Fountain Valley	California	United States	92708
2	UC Davis Health	Sacramento	California	United States	95816
3	Palo Alto Medical Foundation	Sunnyvale	California	United States	94086
4	Delricht Clinical Research - Clinedge - Ppds Baton Rouge	Baton Rouge	Louisiana	United States	70809
5	Aesthetic and Dermatology Center	Rockville	Maryland	United States	20850
6	Tufts Medical Center	Boston	Massachusetts	United States	02111
7	Metro Boston Clinical Partners	Brighton	Massachusetts	United States	02135
8	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01605
9	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
10	Henry Ford Medical Center - New Center One	Detroit	Michigan	United States	48202
11	Austin Institute For Clinical Research Aicr Pflugerville	Pflugerville	Texas	United States	78660
12	Principle Research Solutions	Spokane	Washington	United States	99202
13	Simcomed Health Ltd	Barrie	Ontario	Canada	L4M 7G1
14	Lynderm Research Inc	Markham	Ontario	Canada	L3P 1X2