Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)

• ClinicalTrials.gov Identifier: NCT04057573
• Recruitment Status: Completed
• First Posted: August 15, 2019
• Last Update Posted: March 14, 2022
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Tracking Information

• First Submitted Date: August 14, 2019
• First Posted Date: August 15, 2019
• Last Update Posted Date: March 14, 2022
• Actual Study Start Date: October 3, 2019
• Actual Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 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: Same as current

Current Secondary Outcome Measures (submitted: August 14, 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
• Official Title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): 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: Interventional
• Study Phase: Phase 3

Study Design

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: Non-segmental Vitiligo

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 10, 2020): 344
• Original Estimated Enrollment (submitted: August 14, 2019): 300
• Actual Study Completion Date: October 1, 2021
• Actual Primary Completion Date: March 15, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United States

Administrative Information

• NCT Number: NCT04057573
• Other Study ID Numbers: INCB 18424-307
• 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

• Plan to Share IPD: No

• Responsible Party: Incyte Corporation
• Study Sponsor: Incyte Corporation
• Collaborators: Not Provided

Investigators

• Study Director: Kathleen Butler, MD; Incyte Corporation

• PRS Account: Incyte Corporation
• Verification Date: March 2022