Clinical trial NCT04896385: A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitiligo
Keywords: Vitiligo
depigmenting disorder
topical JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, vehicle-controlled, with an open-label treatment extension.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.


Eligibility criteria: Inclusion Criteria

* A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
* At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
* 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 (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
* Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
* Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
* Conditions at baseline that would interfere with evaluation of vitiligo.
* Use of any protocol-defined treatments within the indicated washout period before baseline.

Primary outcomes:
measure: Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
timeFrame: Baseline; Week 4, Week 12, and Week 24
Secondary outcomes:
measure: Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
timeFrame: Baseline, Week 12, and Week 24
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
timeFrame: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
measure: Number of Participants With TEAEs During the Treatment-Extension Period
timeFrame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
measure: Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period
timeFrame: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
measure: Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period
timeFrame: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Irvine
country: United States
facility: UC Irvine
state: California
city: Washington
country: United States
facility: George Washington Medical Faculty Associates
state: District of Columbia
city: Brooklyn
country: United States
facility: Suny Downstate Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Barrie
country: Canada
facility: Simcoderm Medical and Surgical Dermatology Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Inc
state: Ontario
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Nice
country: France
facility: Hopital Archet 2 Derm Dept
Study officials:
References: