This is a Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive Seamless Design, Phase II/III Study Evaluating the Efficacy and Safety of FXS5626 in Participants With Non-segmental Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study.
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled, adaptive seamless design, Phase II/III study evaluating the efficacy and safety of FXS5626 in participants with non-segmental vitiligo. The study consisted 2 periods: a phase 2 period and a phase 3 period.
Phase 2 design: This period is planned to enroll 120 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:2:1:1 ratio to the FXS5626 75 mg twice daily (BID) group, the FXS5626 50 mg BID group, the FXS5626 25 mg BID group, or the placebo group, with 40, 40, 20, and 20 participants enrolled in each group, respectively. The overall study duration consists of a 4-week screening period, a 24-week double-blind treatment period, and a 4-week safety follow-up period.
Phase 3 design: This period is planned to enroll 360 patients with non-segmental vitiligo. Eligible participants will be randomized in a 2:1 ratio to the FXS5626 group and the placebo group. The overall study duration consists of a 4-week screening period, a 52-week double-blind treatment period, and a 4-week safety follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following inclusion criteria:
- •Understand the trial procedures and methods, voluntarily participate in this trial, be able to communicate well with the investigator, comply with the requirements of the entire study, and provide written informed consent;
- •Screening age must meet the following criteria:
- •1) Age ≥18 years and ≤75 years, regardless sex (Phase 2); 2) Age ≥12 years and ≤75 years, regardless of sex (Phase 3);
- •At screening，participants must have a body mass index (BMI) ≥18 kg/m²; for adolescent participants in the Phase 3, baseline body weight must be ≥40 kg;
- •Clinically diagnosed with non-segmental vitiligo, either active or stable, with a disease history ≥3 months;
- •At the screening and baseline visits, vitiligo lesions must satisfy all of the following criteria:
- •The percentage of vitiligo lesion area relative to the total body surface area (BSA) is ≥3%, excluding involvement of the palms, dorsa of the hands (fingers), soles, and dorsa of the feet;
- •Facial involvement BSA (F-BSA) ≥0.5%;
- •T-VASI ≥0.5 and 3 ≤ T-VASI ≤50;
- •Participants must ensure and agree that, from 28 days before signing the informed consent form to 28 days after the last dose, female participants of childbearing potential, male participants, and their spouses will use effective contraceptive methods other than oral medications (such as condoms or intrauterine devices), and will not donate sperm or ova during this study.
排除标准
- •Presence of vitiligo-related medical conditions and other skin diseases at screening, as assessed by the investigator;
- •Presence of >33% leukotrichia in areas of vitiligo on the face or > 33% leukotrichia in areas of vitiligo on the body (including the face);
- •As assessed by the investigator, accompanied by active infection or history of infection;
- •Patients with a history of severe herpes simplex and herpes zoster infections, or with active/current herpes simplex or herpes zoster infection;
- •Participants with any other clinically significant medical history, or other conditions that, as assessed by the investigator, may affect the participant's safety or compliance, or result in the participant's inability to complete the study.
研究组 & 干预措施
Arm1: FXS5626 25 mg (Phase 2)
FXS5626 25 mg
干预措施: Intervention1: FXS5626 Tablets (Drug)
Arm2: FXS5626 50 mg (Phase 2)
FXS5626 50 mg
干预措施: Intervention2: FXS5626 Tablets (Drug)
Arm3: FXS5626 75 mg (Phase 2)
FXS5626 75 mg
干预措施: Intervention3: FXS5626 Tablets (Drug)
Arm4: FXS5626 group (Phase 3)
FXS5626 group (Dosage will be confirmed after Phase 2)
干预措施: Intervention4: FXS5626 Tablets (Drug)
Arm5: Placebo (Phase 2)
Placebo
干预措施: Intervention5: FXS5626 Placebo Tablets (Drug)
Arm6: Placebo (Phase 3)
Placebo
干预措施: Intervention6: FXS5626 Placebo Tablets (Drug)
结局指标
主要结局
Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24 in Phase 2 study.
时间窗: 24 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome.
Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at Week 52 in Phase 3 study.
时间窗: 52 weeks
The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3. Higher scores of F-VASI mean a worse outcome. F-VASI 75 denotes a at least 75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI).
次要结局
- Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits other than Week 24（Phase 2)(24 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)(24 weeks)
- Change from baseline in the VitiQoL at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90, at least 90% improvement from baseline) at planned visits (Phase 2)(24 weeks)
- Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50, at least 50% improvement from baseline) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75, at least 75% improvement from baseline) at planned visits (Phase 2)(24 weeks)
- Change from baseline in the Facial Body Surface Area (F-BSA) affected by vitiligo at planned visits (Phase 2)(24 weeks)
- Change from baseline in the Total Body Surface Area (T-BSA) affected by vitiligo at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving a score of 0 or 1 on the Facial Physician's Global Vitiligo Assessment (F-PhGVA) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving a score of 0 or 1 on the Total Physician's Global Vitiligo Assessment (T-PhGVA) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving a score of 1 or 2 on the Facial Patient's Global Impression of Change-Vitiligo (F-PaGIC-V) at planned visits (Phase 2)(24 weeks)
- Proportion of participants achieving a score of 1 or 2 on the Total Body Patient's Global Impression of Change-Vitiligo (T-PaGIC-V) at planned visits (Phase 2)(24 weeks)
- Change from baseline in the Vitiligo-Specific Quality of Life (VitiQoL) at planned visits (Phase 2)(24 weeks)
- Number of Participants with Adverse Events (AEs) (Phase 2)(24 weeks and 4 weeks)
- Plasma concentrations of FXS5626 and its metabolite TT-190 (Phase 2)(24 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at Week 52 (Phase 3)(52 weeks)
- Percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 50 (F-VASI 50) at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 75 (F-VASI 75) at planned visits other than Week 52 (Phase 3)(52 weeks)
- Proportion of participants achieving Facial Vitiligo Area Scoring Index 90 (F-VASI 90) at planned visits (Phase 3)(52 weeks)
- Percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 50 (T-VASI 50) at planned visits other than Week 52 (Phase 3)(52 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 75 (T-VASI 75) at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving Total Vitiligo Area Scoring Index 90 (T-VASI 90) at planned visits (Phase 3)(52 weeks)
- Change from baseline in the F-BSA affected by vitiligo at planned visits (Phase 3)(52 weeks)
- Change from baseline in the T-BSA affected by vitiligo at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving a score of 0 or 1 on the F-PhGVA at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving a score of 0 or 1 on the T-PhGVA at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving score of 1 or 2 on the a F-PaGIC-V at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving a score of 1 or 2 on the T-PaGIC-V at planned visits (Phase 3)(52 weeks)
- Change from baseline in the Dermatology Life Quality Index (DLQI)) at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving a DLQI total score of "0" or "1"at planned visits (Phase 3)(52 weeks)
- Proportion of participants achieving a score of 4 or 5 on the Vitiligo Noticeability Scale (VNS) at planned visits (Phase 3)(52 weeks)
- Number of Participants with Adverse Events (AEs) (Phase 3)(52 weeks and 4 weeks)