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Active, Not Recruiting

NCT Number: NCT06113471

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

NonSegmental Vitiligo

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Center Asklepii Ood, Dupnitsa, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Povorcitinib

Drug

Oral, Tablet

Other names: INCB054707

Placebo

Drug

Oral, Tablet

Primary outcomes

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

    Time frame: Week 52

    ≥75% improvement in facial Vitiligo Area Scoring Index.

Secondary outcomes

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

    Time frame: Week 52

    Percentage change from Baseline in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 52

    ≥50% improvement in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 52

    ≥75% improvement in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 52 and Week 104

    VNS is a participant reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable.

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

    Time frame: Up to Week 104 and 30 days

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

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

    Time frame: Week 52 and Week 104

    ≥50% improvement in facial Vitiligo Area Scoring Index.

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

    Time frame: Week 104

    ≥75% improvement in facial Vitiligo Area Scoring Index.

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

    Time frame: Week 52 and Week 104

    ≥90% improvement in facial Vitiligo Area Scoring Index.

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

    Time frame: Week 104

    ≥50% improvement in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 104

    ≥75% improvement in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 52 and Week 104

    ≥90% improvement in total body Vitiligo Area Scoring Index.

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

    Time frame: Week 52 and Week 104

    Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).

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

    Time frame: Week 52 and Week 104

    Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo).

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

    Time frame: Week 52 and Week 104

    Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).

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

    Time frame: Week 52 and Week 104

    Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo).

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

    Time frame: Week 52 and Week 104

    F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).

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

    Time frame: Week 52 and Week 104

    F-PaGIC-V is an assessment of improvement of vitiligo on the face by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).

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

    Time frame: Week 52 and Week 104

    T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).

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

    Time frame: Week 52 and Week 104

    T-PaGIC-V is an assessment of improvement of vitiligo on the total body by the participant. It is a 7-point scale ((1) Very much improved, (2) Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, or (7) Very much worse).

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

    Time frame: Week 52 and Week 104

    Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor.

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

    Time frame: Week 52 and Week 104

    VitiQoL is a 15-item QoL assessment that asks participants to rate various aspects of their condition during the past month using a 7-point scale ("Not at all" to "All of the time").

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

    Time frame: Week 52 and Week 104

    HADS is a 14-item questionnaire that assesses the levels of anxiety and depression that a participant is currently experiencing. There are 7 questions each for measuring anxiety and for measuring depression, with 4 possible responses to each question (responses are scored as 0, 1, 2, or 3).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 2, 2023
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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