NonSegmental Vitiligo
Conditions
Brief summary
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
Interventions
DRUGPovorcitinib
Oral, Tablet
DRUGPlacebo
Oral, Tablet
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) | Week 52 | ≥75% improvement in facial Vitiligo Area Scoring Index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) | Week 52 | Percentage change from Baseline in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) | Week 52 | ≥50% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) | Week 52 | ≥75% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5 | 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. |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | 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. |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | Week 52 and Week 104 | ≥50% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) | Week 104 | ≥75% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190) | Week 52 and Week 104 | ≥90% improvement in facial Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) | Week 104 | ≥50% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) | Week 104 | ≥75% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) | Week 52 and Week 104 | ≥90% improvement in total body Vitiligo Area Scoring Index. |
| Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1 | Week 52 and Week 104 | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). |
| Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category | Week 52 and Week 104 | Global score of vitiligo severity for the face. Scores range from 0 (clear) to 5 (severe vitiligo). |
| Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear) | Week 52 and Week 104 | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). |
| Proportion of participants in each Static Investigator Global Assessment (SIGA) category | Week 52 and Week 104 | Global score of vitiligo severity for the entire body. Scores range from 0 (clear) to 5 (severe vitiligo). |
| Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2 | 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). |
| Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category | 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). |
| Proportion of participants who report Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) of 1 or 2 | 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). |
| Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category | 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). |
| Proportion of participants in each category for the color-matching question | 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. |
| Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) | 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"). |
| Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales | 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). |
Countries
Bulgaria, Canada, France, Germany, Hungary, Italy, Poland, United Kingdom, United States
Contacts
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed