A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo

JRCT ID: jRCT2061240023

Registered date:14/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: NonSegmental Vitiligo
• Date of first enrollment: 28/06/2024
• Target sample size: 444
• Countries of recruitment: United States,Japan,Belgium,Japan,Canada,Japan,France,Japan,Germany,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

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 Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.

Outcome(s)

Primary Outcome

1. Proportion of Participants Achieving a >= 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
[Time Frame: Week 52]

Secondary Outcome

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-PaGIC-V) of 1 or 2
[Time Frame: Week 52 and Week 104]
17. Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category
[Time Frame: Week 52 and Week 104]
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]
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]
20. Proportion of participants in each category for the color-matching question
[Time Frame: Week 52 and Week 104]
21. Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)
[Time Frame: Week 52 and Week 104]
22. Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales
[Time Frame: Week 52 and Week 104]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ono Shintaro
• Secondary ID(s): NCT06113445