Vitiligo

A study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

Incyte Study ID:
INCB54707-303
CT.gov ID:
NCT06113445
Eudra ID:
N/A
EU CT Number:
2023-505782-86-00
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 2027
    TYPE
    Interventional
    PHASE
    Phase 3
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    CLINIQUES UNIVERSITAIRES UCL SAINT-LUC
    WOLUWE-SAINT-LAMBERT, Belgium, 01200
    Name
    HOPITAL UNIVERSITAIRE DE BRUXELLES/ ACADEMISCH ZIEKENHUIS BURSSEL
    BRUSSEL/ BRUSSELS/BRUXELLES, Belgium, 01070
    Name
    CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE - SART TILMAN
    LIEGE, Belgium, 04000
    Name
    UNIVERSITAIR ZIEKENHUIS GENT (UZ GENT)
    GENT, Belgium, 09000
    Name
    NORTH YORK RESEARCH INC.
    NORTH YORK, ON, Canada, M2M 4J5
    Name
    ENVERUS MEDICAL RESEARCH
    SURREY, BC, Canada, V3V 0C6
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    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.
    Requirements information
    Inclusion Criteria
    • • Aged ≥ 18 years.
    • • Clinical diagnosis of nonsegmental vitiligo and meet the following:
    • T-BSA ≥ 5%
    • T-VASI score ≥ 4
    • F-BSA ≥ 0.5%
    • F-VASI score ≥ 0.5
    • • Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
    • • Willingness to avoid pregnancy or fathering children.
    Exclusion Criteria
    • • Other forms of vitiligo or skin depigmentation disorders.
    • • Clinically significant abnormal TSH or free T4 at screening.
    • • Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
    • • Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
    • • History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
    • • Spontaneous and significant repigmentation within 6 months prior to screening.
    • • Women who are pregnant, considering pregnancy, or breast feeding.
    • • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
    • • Evidence of infection with TB, HBV, HCV or HIV.
    • • History of failure to JAK inhibitor treatment of any inflammatory disease.
    • • Laboratory values outside of the protocol-defined ranges.
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

    Protocol Summary

    Incyte Study ID:
    INCB54707-303
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Triple (Participant, Investigator, Outcomes Assessor)
    Interventions:
  • Drug: Povorcitinib
  • Drug: Placebo
    • Enrollment:
    467
    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-VASI90)

    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