A Phase 2a, Proof of Concept, Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of ACT-777991 in Adults With Non-segmental Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
The purpose of this clinical trial is to learn how well ACT-777991 works, how safe it is and how well it is tolerated by adults with non-segmental vitiligo.
The main question this clinical trial aims to answer is:
• Can ACT-777991 help return color to the skin of the face of adults with non-segmental vitiligo?
Researchers will compare ACT-777991 to placebo (a look-alike inactive treatment that contains no medicine) to see if ACT-777991 works to treat non-segmental vitiligo.
Trial participants will:
- Take the trial intervention (either ACT-777991 or placebo) daily for 24 weeks.
- Visit the clinic 7 times for check-up and tests.
详细描述
The trial includes three trial periods:
Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 2:1 ratio to receive either ACT-777991 or placebo for 24 weeks (Trial intervention period). On completion of treatment, participants will be followed for 30 (+7) days (Follow-up period).
Trial participation will end with a Follow-up visit (Participant Last Visit) at the end of the Follow-up period.
The maximum trial duration for an individual participant is approximately 33 weeks including a screening period of up to 28 days, a treatment period of 24 weeks, and a follow-up period of up to 37 days.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of either active or stable non segmental vitiligo for at least 3 months prior to Screening and meet all the following criteria:
- •F-VASI score ≥ 0.3 based on BICR at Screening.
- •T-VASI score ≥ 5 based on investigator assessment at Screening and Randomization.
- •Total body surface area (BSA) involvement, including the face, ≤ 50% based on investigator assessment at Screening and Randomization.
- •Participants must agree not to use therapeutic agents and procedures to treat vitiligo from Screening until Participant Last Visit.
排除标准
- •Clinical diagnosis of other forms of vitiligo (e.g., segmental) or other hypo- or depigmentation disorders (e.g., piebaldism, leukoderma, Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation).
- •Any autoimmune disease, except adequately treated thyroid disease.
- •History of systemic immunotherapy treatment, including JAK inhibitors, for any inflammatory disease in the 12 months prior to Randomization.
- •History of topical JAK inhibitors for any inflammatory disease in the 6 weeks prior to Screening.
- •Use of laser or light-based treatment (phototherapy), including tanning beds, in the 8 weeks prior to Screening.
- •eGFR < 90 mL/min/1.73 m2, defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, at Screening.