NCT06113471进行中（未招募）3 期
A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 160
- 主要终点
- Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
研究概览
简要总结
This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Experimental: Povorcitinib Dose A
Experimental
Participants will receive Povorcitinib Dose A for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
干预措施: Povorcitinib (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo for 52 weeks, followed by Povorcitinib Dose A for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
时间窗: Week 52
≥75% improvement in facial Vitiligo Area Scoring Index.
次要结局
- Percentage change from Baseline in Total Body Vitiligo Area Scoring Index (T-VASI)(Week 52)
- Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 52)
- Proportion of participants achieving a Vitiligo Noticeability Scale Score (VNS) of 4 or 5(Week 52 and Week 104)
- Number of participants with Treatment-emergent Adverse Events (TEAEs)(Up to Week 104 and 30 days)
- Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75)(Week 52)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)(Week 104)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VAS190)(Week 52 and Week 104)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 104)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)(Week 104)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)(Week 52 and Week 104)
- Proportion of participants achieving an Facial Static Investigator Global Assessment (FSIGA) of 0 or 1(Week 52 and Week 104)
- Proportion of participants in each Facial Static Investigator Global Assessment (FSIGA) category(Week 52 and Week 104)
- Proportion of participants achieving a Static Investigator Global Assessment (SIGA) of 0 (clear) or 1 (almost clear)(Week 52 and Week 104)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)(Week 52 and Week 104)
- Proportion of participants in each Static Investigator Global Assessment (SIGA) category(Week 52 and Week 104)
- Proportion of participants who report Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) of 1 or 2(Week 52 and Week 104)
- Proportion of participants in each Facial Patient Global Impression of Change-Vitiligo (F-PaGIC-V) category(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(Week 52 and Week 104)
- Proportion of participants in each Total Body Patient Global Impression of Change-Vitiligo (T-PaGIC-V) category(Week 52 and Week 104)
- Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL)(Week 52 and Week 104)
- Proportion of participants in each category for the color-matching question(Week 52 and Week 104)
- Change from baseline in the Hospital Anxiety and Depression Scale (HADS) subscales(Week 52 and Week 104)
研究者
研究点 (160)
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