A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 394
- 试验地点
- 116
- 主要终点
- Incidence of clinically significant laboratory abnormalities
研究概览
简要总结
This study is to evaluate how safe and effective ritlecitinib is in participants with non-segmental vitiligo (NSV).
Ritlecitinib is studied in patients with non-segmental vitiligo. Vitiligo is a chronic acquired depigmentation disorder characterized by well-defined pale white patches of skin.
Non-segmental vitiligo is an autoimmune disorder and is the focus of this study. The study will show:
- if the repigmentation (the recovery of pigmentation) achieved in study B7981040 (also called the "parent study") will stay the same or will further increase if you keep receiving the same study medicine (ritlecitinib 50 milligrams or placebo)
- Or if more repigmentation can be achieved if you start receiving ritlecitinib 100 milligrams in this study
- Or how long the repigmentation achieved during the parent study lasts if you start receiving placebo in this study.
This study is seeking for participants who:
- have non-segmental vitiligo (either active or stable) and
- received ritlecitinib or placebo for 52 weeks in the parent study. A placebo looks exactly like the study capsule but does not contain any medicine in it.
All participants in this study will receive the study medicine or placebo. The study medicine (ritlecitinib 50 milligrams or 100 milligrams) or placebo are capsules that are taken by mouth at home every day. On study visit days, you must take the medication at the study site, and not at home.
Participants may receive the study medicine or placebo for up to 52 weeks.
The study will look at the experiences of people receiving the study medicine. This will help see if ritlecitinib is better for treating vitiligo.
Participants will be involved in this study for a maximum of 60 weeks. During this time, they will have 9 study visits during the study.
Ritlecitinib 50 mg is an approved drug for the treatment of severe Alopecia Areata (a disease with similar abnormal changes in the body functions like vitiligo) in the US, EU and Japan. China, Great Britain and other market applications are pending.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority.
- Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040
- The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040
排除标准
- Participant met the parent study (Study 7981040) discontinuation criteria or discontinued the parent study for any safety-related event
- Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation
研究组 & 干预措施
Arm 1
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040.
Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
干预措施: Ritlecitinib 100 mg (Drug)
Arm 2
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
干预措施: Ritlecitinib 100 mg (Drug)
Arm 1
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040.
Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
干预措施: Ritlecitinib (Drug)
Arm 2
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
干预措施: Ritlecitinib (Drug)
Arm 1
Participants who previously received 1 ritlecitinib 50 mg capsule QD orally from BL to Week 52 in Study B7981040.
Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned.
干预措施: Placebo (Drug)
Arm 2
Participants who previously received 1 placebo 50 mg capsule QD orally from BL to Week 52 in Study B7981040 Ritlecitinib 50 mg or Ritlecitinib 100 mg or Placebo will be assigned
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of clinically significant laboratory abnormalities
时间窗: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
时间窗: Screening up to at least 30 days after last dose of study drug (week 52 or Early Termination)
To evaluate the long-term safety and tolerability of ritlecitinib in adult and adolescent participants with non-segmental vitiligo
次要结局
- Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52(Baseline to week 52)
- Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52(Baseline to week 52)
- Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52(Baseline to week 52)
- Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52(Baseline to week 52)
- Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52(Baseline to Week 52)
- Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52(Baseline to week 52)
- Proportion of participants achieving disease stabilization(Baseline to week 52)
- Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52(Baseline to week 52)
- Response based on T-VASI75 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI75 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI50 at weeks 4, 8, 12, 24, 36 and 52(Baseline to Week 52)
- Response based on F-VASI50 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI90 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI90 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on T-VASI100 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Response based on F-VASI100 at weeks 4, 8, 12, 24, 36 and 52(Baseline to week 52)
- Patient Global Impression of Severity-Face (PGIS-F) at weeks 24, 36, and 52(Baseline to week 52)
- Patient Global Impression of Severity-Overall Vitiligo (PGIS-V) at weeks 24, 36, and 52(Baseline to week 52)
- Patient Global Impression of Change-Face (PGIC-F) at week 24, 36, and 52(Baseline to week 52)
- Patient Global Impression of Change- Overall vitiligo (PGIC-V) at weeks 24, 36, and 52(Baseline to week 52)
- Proportion of participants achieving disease stabilization(Baseline to week 52)
- Percentage change from baseline (%CFB) in F-VASI at weeks 4, 8, 12, 24, 36, and 52(Baseline to week 52)
- Percentage change from baseline (%CFB) in T-VASI at weeks 4, 8, 12, 24, 36, and 52(Baseline to week 52)
- Time to loss of response (<F-VASI75 and <T-VASI50 at the same visit).(Baseline to week 52)
研究者
研究点 (116)
标识符
- NCT 编号
- NCT06163326
- 其他研究编号
- B7981041, 2023-505804-42-00, 2023
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (6个月后)
- 研究完成日期
- (6个月后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.