Vitiligo

A study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V2)

Incyte Study ID:
INCB54707-304
CT.gov ID:
NCT06113471
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruitment Complete
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Clinical Study Purpose

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Vitiligo
    • PRODUCT
  • Drug: Povorcitinib
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Nov 2023 - May 2026
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Aged ≥ 18 years.
    • Clinical diagnosis of nonsegmental vitiligo and meet the following:

    Exclusion Criteria

    • Other forms of vitiligo or skin depigmentation disorders.
    • Clinically significant abnormal TSH or free T4 at screening.

    Clinical Study Locations

    Location
    Status
    Location
    AMBULATORY FOR SPECIALIZED MEDICAL CARE - INDIVIDUAL PRACTICE FOR SPECIALIZED MEDICAL CARE - SKIN AN
    SOFIA, Bulgaria, 01407
    Status
    Recruiting
    Location
    ALEKSANDROVSKA UNIVERSITY HOSPITAL
    SOFIA, Bulgaria, 01431
    Status
    Completed
    Location
    MEDICAL CENTER UNIMED EOOD
    SLIVEN, Bulgaria, 05308
    Status
    Recruiting
    Location
    28 DIAGNOSTIC AND CONSULTATIVE CENTER
    SOFIA, Bulgaria, 01528
    Status
    Recruiting
    Location
    MEDICAL CENTER ASKLEPII OOD
    DUPNITSA, Bulgaria, 02600
    Status
    Recruiting
    Location
    LYNDERM RESEARCH INC
    MARKHAM, ON, Canada, L3P 1X2
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB54707-304
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    450
    Primary Outcome
    Open

    Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)

    Timeframe: Week 52

    Secondary Outcome
    Open

    Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)

    Timeframe: Week 52

    Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)

    Timeframe: Week 52

    Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)

    Timeframe: Week 52

    Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5

    Timeframe: Week 52 and Week 104

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to Week 104 and 30 days

    Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)

    Timeframe: Week 52 and Week 104

    Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)

    Timeframe: Week 104

    Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)

    Timeframe: Week 52 and Week 104

    Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)

    Timeframe: Week 104

    Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)

    Timeframe: Week 104

    Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)

    Timeframe: Week 52 and Week 104

    Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1

    Timeframe: Week 52 and Week 104

    Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category

    Timeframe: Week 52 and Week 104

    Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)

    Timeframe: Week 52 and Week 104

    Proportion of participants in each Static Investigator Global Assessment (SIGA) category

    Timeframe: Week 52 and Week 104

    Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2

    Timeframe: Week 52 and Week 104

    Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category

    Timeframe: Week 52 and Week 104

    Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2

    Timeframe: Week 52 and Week 104

    Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category

    Timeframe: Week 52 and Week 104

    Proportion of participants in each category for the color-matching question

    Timeframe: Week 52 and Week 104

    Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)

    Timeframe: Week 52 and Week 104

    Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales

    Timeframe: Week 52 and Week 104