NCT03817164Unknown不适用
Multicenter, Randomized, Double-Blind, Sham-Controlled, Efficacy and Safety Study of Autonomic Nerve Modulation (ANM) in Subjects With Moderate Plaque Psoriasis
Thync Global, Inc.1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年10月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- BSA x sPGA average percent change from Baseline
研究概览
简要总结
This is a 16-week, prospective, multicenter, double-blind, controlled, randomized study assessing change in psoriasis severity and level of stress in patients with moderate psoriasis treated with ANM. Psoriasis severity and stress levels will be measured at Weeks 0, 2, 8, 12, and 16.
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
- Double (Participant, Investigator)
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
- •Outpatient, male or female of any race, 18 years of age or older. This study has no pregnancy restrictions.
- •BSA* <10% (excluding palms, soles, intertriginous and inverse areas).
- •sPGA* ≥3 (NOTE: sPGA score will be averaged across all lesions as opposed to grading target lesions).
- •BSA x sPGA ≥
- •Subject diagnosed with chronic plaque psoriasis at least 6 months prior to screening.
- •Treatment-naïve of prohibited biological immunomodulating agents at the time of screening, or decided to stop treatment with the biologic before screening for the study.
- •Be able to follow study instructions and likely to complete all required visits.
- •Sign the IRB-approved ICF (which includes HIPAA).
排除标准
- •Non-plaque psoriasis (erythrodermic or pustular), guttate, inverse psoriatic arthritis, or drug-induced psoriasis.
- •Subjects with plaque psoriasis on palms and soles at enrolment.
- •Subjects with plaque psoriasis on the back of the neck that would interfere with device placement.
- •Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis.
- •Other than psoriasis, history of any clinically significant (as determined by Investigator) or other major uncontrolled disease.
- •Psoriasis flare or rebound within 4 weeks of Visit 1 or spontaneously improving or rapidly deteriorating plaque psoriasis during that same time period, as determined by investigator.
- •Use of prohibited medications within the following washout periods:
- •Biological immunomodulating agents within the prior 12 weeks: etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab pegol (Cimzia), ixekizumab (Taltz)
- •Biological immunomodulating agents within the prior 24 weeks: ustekinumab (Stelara), secukinumab (Cosentyx), guselkumba (Tremfaya)
- •Oral drugs within the prior 4 weeks: apremilast, methotrexate, cyclosporine, corticosteroids
- •Oral drugs within the prior 12 weeks: acitretin
- •Photochemotherapy (PUVA) within the prior 4 weeks
- •Phototherapy (UVA/UVB) within the prior 2 weeks
- •Topical treatment likely to impact signs and symptoms of psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, lactic acid, tar, urea, etc.) within the prior 2 weeks
- •Prolonged sun exposure or use of tanning booths or other source of UV radiation.
- •Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for entry into this study.
- •Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- •Exposure to any other investigational drug/device within 30 days prior to study entry.
- •Subjects with a pacemaker, or any type of metal implant in the neck (i.e., T5 and above).
研究组 & 干预措施
Active Treatment
Active Comparator
Active stimulation pulsed current delivered over 15 minutes.
干预措施: Autonomic Nerve Modulation - Active (Device)
Control Treatment
Sham Comparator
Active stimulation pulsed current (alternative frequency) delivered over 15 minutes.
干预措施: Autonomic Nerve Modulation - Control (Device)
结局指标
主要结局
BSA x sPGA average percent change from Baseline
时间窗: Week 16
Body Surface Area x Static Physician Global Assessment
次要结局
- sPGA change from Baseline(Week 16)
- BSA change from Baseline(Week 16)
- Mean PASI change from Baseline(Week 16)
- PASI 50(Week 16)
- PASI 75(Week 16)
- PSSI change from Baseline(Week 16)
- QVAS change from Baseline(Week 16)
- DLQI change from Baseline(Week 16)
- HADS change from Baseline(Week 16)
- Pruritus NRS change from Baseline(Week 16)
- Pruritus NRS responder rate (i.e., proportion of subjects achieving a ≥4-point improvement)(Week 16)
- PQOL-12 change from Baseline(Week 16)
- TSQM(Week 16)
研究者
研究点 (1)
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