NonSegmental Vitiligo
Conditions
Interventions
Experimental: Povorcitinib Dose A
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
Placebo Comparator: Placebo
Participants will receive Place
Sponsors
Ono Shintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years. 2. Clinical diagnosis of nonsegmental vitiligo and meet the following: a. T-BSA >= 5% b. T-VASI score >= 4 c. F-BSA >= 0.5% d. F-VASI score >= 0.5 3. Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit. 4. Willingness to avoid pregnancy or fathering children.
Exclusion criteria
Exclusion criteria: 1. Other forms of vitiligo or skin depigmentation disorders. 2. Clinically significant abnormal TSH or free T4 at screening. 3. Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1. 4. Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin(R). 5. History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. 6. Spontaneous and significant repigmentation within 6 months prior to screening. 7. Women who are pregnant, considering pregnancy, or breast feeding. 8. 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. 9. Evidence of infection with TB, HBV, HCV or HIV. 10. History of failure to JAK inhibitor treatment of any inflammatory disease. 11. Laboratory values outside of the protocol-defined ranges.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of Participants Achieving a >= 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) [Time Frame: Week 52] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) [Time Frame: Week 52] 2. Proportion of Participants Achieving a >= 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) [Time Frame: Week 52] 3. Proportion of Participants Achieving a >= 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) [Time Frame: Week 52] 4. Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5 [Time Frame: Week 52 and Week 104] 5. Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to Week 104 and 30 days] 6. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) [Time Frame: Week 52 and Week 104] 7. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) [Time Frame: Week 104] 8. Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) [Time Frame: Week 52 and Week 104] 9. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) [Time Frame: Week 104] 10. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) [Time Frame: Week 104] 11. Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) [Time Frame: Week 52 and Week 104] 12. Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1 [Time Frame: Week 52 and Week 104] 13. Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category [Time Frame: Week 52 and Week 104] 14. Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 or 1 [Time Frame: Week 52 and Week 104] 15. Proportion of participants in each Static Investigator Global Assessment (SIGA) category [Time Frame: Week 52 and Week 104] 16. Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-P | — |
Countries
Belgium, Canada, France, Germany, Japan, Mexico, Netherlands, Poland, Spain, United States
Contacts
Public ContactMedical Information Center
Incyte Biosciences Japan G.K.
Outcome results
None listed