Clinical trial NCT05247489: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Official title: A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitiligo
Keywords: Non-segmental
Vitiligo
hypopigmentation
Pigment Disorders
Skin Diseases
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
timeFrame: Baseline; Week 48
Secondary outcomes:
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately 52 weeks
measure: Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Change From Baseline in F-VASI at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Change From Baseline in T-VASI at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit
timeFrame: Baseline; up to Week 48
measure: Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16
timeFrame: pre-application at Weeks 4, 12, and 16
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Sunnyvale
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Baton Rouge
country: United States
facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge
state: Louisiana
city: Rockville
country: United States
facility: Aesthetic and Dermatology Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Brighton
country: United States
facility: Metro Boston Clinical Partners
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: Spokane
country: United States
facility: Principle Research Solutions
state: Washington
city: Barrie
country: Canada
facility: Simcomed Health Ltd
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: