Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

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: NCT04052425
Recruitment Status : Active, not recruiting
First Posted : August 9, 2019
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 9, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE September 20, 2019
Actual Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Proportion of participants achieving F-VASI75 [ Time Frame: Week 24 ]
≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
  • Percentage change from baseline in facial body surface area (F-BSA) [ Time Frame: Week 24 ]
  • Proportion of participants achieving F-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement from baseline in F-VASI score.
  • Proportion of participants achieving F-VASI75 [ Time Frame: Week 52 ]
    ≥ 75% improvement from baseline in F-VASI score.
  • Proportion of participants achieving F-VASI90 [ Time Frame: Week 24 ]
    ≥ 90% improvement from baseline in F-VASI score.
  • Proportion of participants achieving F-VASI90 [ Time Frame: Week 52 ]
    ≥ 90% improvement from baseline in F-VASI score.
  • Proportion of participants achieving T-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).
  • Proportion of participants achieving T-VASI50 [ Time Frame: Week 52 ]
    ≥ 50% improvement in T-VASI.
  • Proportion of participants achieving T-VASI75 [ Time Frame: Week 52 ]
    ≥ 75% improvement in T-VASI.
  • Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable" [ Time Frame: Week 24 ]
  • Number of treatment-emergent adverse events [ Time Frame: Up to 56 weeks ]
    Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
  • Proportion of participants achieving F-VASI25/50/75/90 [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
    ≥ 25%/ 50%/ 75%/90% improvement from baseline in F-VASI score.
  • Percentage change from baseline in F-VASI [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  • Percentage change from baseline in F-BSA [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  • Percentage change from baseline in T-VASI [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  • Percentage change from baseline in total body surface area (T-BSA) [ Time Frame: From baseline to during the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  • Proportion of participants achieving T-VASI25/50/75/90 [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
    ≥ 25%/ 50%/ 75%/90% improvement in T-VASI.
  • Proportion of participants in each category of VNS [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  • Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 4 ]
  • Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 24 ]
  • Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 40 ]
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 Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
Official Title  ICMJE Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo
Brief Summary The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-segmental 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
    Vehicle cream is a topical formulation applied as a thin film to affected areas.
Study Arms  ICMJE
  • Experimental: Ruxolitinib cream
    Ruxolitinib cream 1.5% twice daily (BID) for 24 weeks followed by ruxolitinib cream 1.5% BID for an additional 28-week treatment extension period.
    Intervention: Drug: Ruxolitinib cream
  • Placebo Comparator: Vehicle
    Vehicle cream for 24 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 28-week treatment extension period.
    Intervention: Drug: Vehicle
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: October 28, 2020)
330
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
300
Estimated Study Completion Date  ICMJE October 30, 2021
Actual Primary Completion Date April 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and 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.
  • Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Key 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).
  • Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
  • Use of protocol-defined treatments within the indicated washout period before baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, 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 Bulgaria,   Canada,   France,   Germany,   Italy,   Poland,   Spain,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT04052425
Other Study ID Numbers  ICMJE INCB 18424-306
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 May 2021

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