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A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099304
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE April 19, 2017
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Percentage of participants treated with ruxolitinib cream who achieve a ≥ 50% improvement in facial assessment of the Vitiligo Area and Severity Index score (F-VASI50) compared with participants treated with vehicle [ Time Frame: Week 24 ]
F-VASI is the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%) and estimated by the investigator using the palmar method.
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Percentage of participants treated with INCB018424 cream who achieve a ≥ 50% improvement in facial assessment of the Vitiligo Area and Severity Index score (F-VASI50) compared with participants treated with vehicle [ Time Frame: Week 24 ]
F-VASI is the percentage of depigmented vitiligo skin expressed as a percentage of the total area of skin on the face (100%) and estimated by the investigator using the palmar method.
Change History Complete list of historical versions of study NCT03099304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Percentage of participants who achieve a facial assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of clear or almost clear [ Time Frame: Week 24 ]
    F-PhGVA has a 5-point scale (clear, almost clear, mild disease, moderate disease, and severe disease) assessed by the physician to determine the severity of vitiligo and will be reported for face and overall. Complete facial repigmentation is defined as an F-PhGVA of clear (0).
  • Percentage of participants who achieve a ≥ 50% improvement from baseline in full body assessment of Vitiligo Area and Severity Index (T-VASI) [ Time Frame: Week 52 ]
    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.
  • Safety and tolerability assessed by monitoring the frequency, duration, and severity of adverse events (AEs) [ Time Frame: Screening through at least 30 days after the last dose of study drug, up to 120 weeks per participant ]
    AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Official Title  ICMJE A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
Brief Summary The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • Drug: Ruxolitinib cream
    Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
    Other Name: INCB018424 cream
  • Drug: Vehicle cream
    Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Study Arms  ICMJE
  • Experimental: Ruxolitinib cream 1.5% twice daily (BID)
    Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 52-week open-label extension.
    Intervention: Drug: Ruxolitinib cream
  • Experimental: Ruxolitinib cream 1.5% once daily (QD)
    Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 52-week open-label extension.
    Interventions:
    • Drug: Ruxolitinib cream
    • Drug: Vehicle cream
  • Experimental: Ruxolitinib cream 0.5% QD
    Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 52-week open-label extension.
    Interventions:
    • Drug: Ruxolitinib cream
    • Drug: Vehicle cream
  • Experimental: Ruxolitinib cream 0.15% QD
    Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 52-week open-label extension.
    Interventions:
    • Drug: Ruxolitinib cream
    • Drug: Vehicle cream
  • Placebo Comparator: Vehicle BID
    Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 52-week open-label extension.
    Interventions:
    • Drug: Ruxolitinib cream
    • Drug: Vehicle cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 4, 2019)
157
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
150
Estimated Study Completion Date  ICMJE July 2020
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099304
Other Study ID Numbers  ICMJE INCB 18424-211
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kathleen Butler, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP