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

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Non-segmental Vitiligo Drug: Ruxolitinib cream Drug: Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
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
Official Title: 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
Actual Study Start Date : September 20, 2019
Actual Primary Completion Date : April 18, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Name: INCB018424 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.
 Drug: Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants achieving F-VASI75 [ Time Frame: Week 24 ]
    ≥ 75% improvement from baseline in Face Vitiligo Area Scoring Index (F-VASI) score.


Secondary Outcome Measures :
  1. Percentage change from baseline in facial body surface area (F-BSA) [ Time Frame: Week 24 ]
  2. Proportion of participants achieving F-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement from baseline in F-VASI score.

  3. Proportion of participants achieving F-VASI75 [ Time Frame: Week 52 ]
    ≥ 75% improvement from baseline in F-VASI score.

  4. Proportion of participants achieving F-VASI90 [ Time Frame: Week 24 ]
    ≥ 90% improvement from baseline in F-VASI score.

  5. Proportion of participants achieving F-VASI90 [ Time Frame: Week 52 ]
    ≥ 90% improvement from baseline in F-VASI score.

  6. Proportion of participants achieving T-VASI50 [ Time Frame: Week 24 ]
    ≥ 50% improvement in total body Vitiligo Area Scoring Index (T-VASI).

  7. Proportion of participants achieving T-VASI50 [ Time Frame: Week 52 ]
    ≥ 50% improvement in T-VASI.

  8. Proportion of participants achieving T-VASI75 [ Time Frame: Week 52 ]
    ≥ 75% improvement in T-VASI.

  9. Proportion of participants achieving a Vitiligo Noticeability Scale (VNS) of "4 - A lot less noticeable" or "5 - No longer noticeable" [ Time Frame: Week 24 ]
  10. 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.

  11. 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.

  12. 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. ]
  13. 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. ]
  14. 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. ]
  15. 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. ]
  16. 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.

  17. Proportion of participants in each category of VNS [ Time Frame: During the treatment period (double-blind and treatment extension periods), up to 52 weeks. ]
  18. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 4 ]
  19. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 24 ]
  20. Population-based (trough) plasma concentrations of ruxolitinib [ Time Frame: Week 40 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052425


Locations
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Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04052425    
Other Study ID Numbers: INCB 18424-306
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Vitiligo
non-segmental
JAK inhibitor
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases