Clinical trial NCT03099304: A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Official title: A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With 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: 2017-04-04
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of vitiligo.
* Vitiligo with depigmented areas including:

  * at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm \[without digits\]) AND
  * at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints \[palm plus 5 digits\]).
* Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

Exclusion Criteria:

* Conditions at baseline that would interfere with evaluation of vitiligo.
* Participants who are receiving any kind of phototherapy, including tanning beds.
* Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
* Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
* Participants who have received any of the following treatments within the minimum specified timeframes.

  * Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
  * Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
  * Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
* Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
* Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
* Participants with protocol-defined cytopenias at screening
* Participants with severely impaired liver function.
* Participants with impaired renal function.
* Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
* Participants who have previously received JAK inhibitor therapy, systemic or topical.

Primary outcomes:
measure: Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear
timeFrame: Week 24
measure: Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52
timeFrame: Baseline; Week 52
measure: Dose Response on Percentage Change From Baseline in F-VASI
timeFrame: up to 156 weeks
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24
timeFrame: up to 24 weeks
measure: Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52
timeFrame: up to 52 weeks
measure: Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52
timeFrame: Week 24 to Week 52
measure: Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE
timeFrame: up to Week 156
measure: Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156
timeFrame: Week 52 to Week 156
measure: Mean Change From Baseline in F-VASI Score at Week 24
timeFrame: Baseline; Week 24
measure: Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage Change From Baseline in F-VASI Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage Change From Baseline in F-BSA Repigmentation at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage Change From Baseline in T-BSA Repigmentation at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Mean Change From Baseline in T-VASI Score at Week 24
timeFrame: Baseline; Week 24
measure: Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage Change From Baseline in T-VASI Score at Week 24
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading
timeFrame: Baseline; Week 24
measure: Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading
timeFrame: Baseline; Weeks 52 and 104
measure: Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area
timeFrame: Baseline; Week 24
measure: Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area
timeFrame: Baseline; Weeks 52 and 104
measure: Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area
timeFrame: Baseline; Weeks 52 and 104
measure: Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging
timeFrame: Baseline; Week 24
measure: Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging
timeFrame: Baseline; Weeks 52 and 104
measure: Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging
timeFrame: Baseline; Week 24
measure: Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging
timeFrame: Baseline; Weeks 52 and 104
measure: Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24
timeFrame: Week 24
measure: Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156
timeFrame: Weeks 52, 104, and 156
measure: Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24
timeFrame: Week 24
measure: Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156
timeFrame: Weeks 52, 104, and 156
measure: Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24
timeFrame: Week 24
measure: Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156
timeFrame: Weeks 52, 104, and 156
measure: Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24
timeFrame: Week 24
measure: Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156
timeFrame: Weeks 52, 104, and 156
measure: Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24
timeFrame: Baseline; Week 24
measure: Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156
timeFrame: Baseline; Weeks 52, 104, and 156
measure: Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score
timeFrame: up to 52 weeks
measure: Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score
timeFrame: up to 52 weeks
measure: Time to Achieve an F-PhGVA of Clear or Almost Clear
timeFrame: up to 52 weeks
measure: Time to Achieve an T-PhGVA of Clear or Almost Clear
timeFrame: up to 52 weeks
measure: Time to Achieve a PaGIC-V of Very Much Improved or Much Improved
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB), 1802 6th Ave S
state: Alabama
city: Hot Springs
country: United States
facility: BURKE PHARMACEUTICAL RESEARCH LLC, 3633 Central Ave
state: Arkansas
city: Rogers
country: United States
facility: NORTHWEST AR CLINICAL TRIALS CENTER, PLLC/HULL DERMATOLOGY, PA, 500 S 52nd Street
state: Arkansas
city: Los Angeles
country: United States
facility: THE VITILIGO & PIGMENTATION INSTITUE OF SOUTHERN CALIFORNIA, 5670 Wilshire Boulevard
state: California
city: Los Angeles
country: United States
facility: DERMATOLOGY RESEARCH ASSOCIATES- LOS ANGELES, 8930 S Sepulveda Blvd
state: California
city: Oceanside
country: United States
facility: DERMATOLOGY SPECIALISTS, 3629 Vista Way
state: California
city: Danbury
country: United States
facility: CLINICAL RESEARCH CENTER OF CT, 27 Hospital Avenue
state: Connecticut
city: Ormond Beach
country: United States
facility: LEAVITT MEDICAL ASSOCIATES OF FLORIDA INC/ AMERIDERM RESEARCH, 725 W Granada Blvd
state: Florida
city: Atlanta
country: United States
facility: EMORY UNIVERSITY, 1525 Clifton Road
state: Georgia
city: Chicago
country: United States
facility: NORTHWESTERN UNIVERSITY, 676 N Saint Clair
state: Illinois
city: Indianapolis
country: United States
facility: DAWES FRETZIN CLINICAL RESEARCH GROUP, 8103 Clearvista Parkway
state: Indiana
city: New Albany
country: United States
facility: DS RESEARCH, 2241 Green Valley Road
state: Indiana
city: New Orleans
country: United States
facility: TULANE UNIVERSITY, 1415 Tulane Avenue
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center, 260 Tremont Street
state: Massachusetts
city: Worcester
country: United States
facility: UNIVERSITY OF MASSACHUESETTS, 364 Plantation Street
state: Massachusetts
city: Detroit
country: United States
facility: HAMZAVI DERMATOLOGY, 3031 W Grand Blvd
state: Michigan
city: Saint Louis
country: United States
facility: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE DERMATOLOGY, 969 N. Mason Road
state: Missouri
city: Portsmouth
country: United States
facility: ACTIVMED PRACTICES & RESEARCH, INC, 110 Corporate Drive
state: New Hampshire
city: New York
country: United States
facility: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI MEDICAL CENTER- DERMATOLOGY ASSOCIATES, 5 E 98th Street
state: New York
city: Winston-Salem
country: United States
facility: WAKE FOREST UNIVERSITY HEALTH SCIENCES, Medical Center Boulevard
state: North Carolina
city: Norman
country: United States
facility: CENTRAL SOONER RESEARCH, 900 N Porter Ave
state: Oklahoma
city: Providence
country: United States
facility: RHODE ISLAND HOSPITAL, 593 Eddy Street
state: Rhode Island
city: Arlington
country: United States
facility: ARLINGTON RESEARCH CENTER, INC., 711 East Lamar Boulevard
state: Texas
city: Dallas
country: United States
facility: MENTER DERMATOLOGY RESEARCH INSTITUTE, 3900 Junius Street
state: Texas
city: Dallas
country: United States
facility: UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, DEPARTMENT OF DERMATOLOGY, 5323 Harry Hines Blvd
state: Texas
city: San Antonio
country: United States
facility: THE DERMATOLOGY AND LASER CENTER OF SAN ANTONIO, 7810 Louis Pasteur
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
citation: Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, Butler K, Kuo F, Sun K, Ji T, Howell MD, Harris JE. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7.