NCT03322137已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b, Multicenter Study to Evaluate the Safety, Efficacy, and Tolerability of SNA-120 (Pegcantratinib) Ointment in Subjects With Pruritus Associated With Psoriasis Vulgaris
Sienna Biopharmaceuticals38 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2017年10月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 38
- 主要终点
- Change in Itch Numeric Rating Scale scores (I-NRS)
研究概览
简要总结
To characterize the efficacy, safety and tolerability of SNA-120 at 2 doses versus placebo when administered topically for the treatment of pruritus associated with psoriasis vulgaris (PV) and PV itself.
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, Outcomes Assessor)
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
- •Informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Stable PV for at least 6 months prior to screening
- •Chronic pruritus of the PV plaques to be present for at least 6 weeks prior to screening
- •Mild to moderate PV at screening and baseline
- •Has a target plaque at baseline on the trunk and/or limbs
- •Subject's plaques are amenable to treatment with a topical ointment medication
- •Willing and able to comply with the study instructions and attend all scheduled study visits.
- •Willing to avoid prolonged exposure of the designated treatment plaques to ultraviolet radiation
- •Females of childbearing potential must have a negative pregnancy test at baseline before randomization and must agree to use highly effective contraception during the study
- •Men who are sexually active and can father children must agree to use highly effective forms of contraception during the study
排除标准
- •Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin
- •Positive hepatitis serology
- •Thyroid abnormalities that may impact itching
- •Subjects with spontaneously improving or rapidly deteriorating PV and/or pruritus
- •Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
- •Active psoriasis or itch affecting the palmar/plantar regions
- •Subjects with a clinical diagnosis of bacterial infection of the skin
- •Any major medical illness or symptoms of a clinically significant illness that may influence the study outcome
- •Any acute chronic medical or psychiatric condition or laboratory abnormality that would make them unsuitable for participation in this study
- •Known hypersensitivity to the study treatment excipients and /or polyethylene glycol, that contraindicates participation
- •Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days of randomization/baseline (Note: Subjects who are enrolled in a long-term follow-up study and are not actively receiving an investigational drug or investigational device treatment may be eligible for participation in this study)
- •Female who is pregnant or lactating, or is planning to become pregnant during the study
- •Subjects participating in any previous SNA-120 (and/or CT327) clinical studies
研究组 & 干预措施
SNA-120 (0.05% )
Active Comparator
Pegcantratinib Ointment
干预措施: SNA-120 (Drug)
SNA-120 (0.5%)
Active Comparator
Pegcantratinib Ointment
干预措施: SNA-120 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Change in Itch Numeric Rating Scale scores (I-NRS)
时间窗: week 8
The I-NRS is a 11 point scale, where "0" represents no itch and "10" represents worst possible itching
次要结局
- Proportion of subjects (≥ 1 grade change) on IGA scale(week 12)
- Proportion of subjects categorized as a "0" or "1" on IGA scale and minimum improvement of 2 categories(baseline and week 12)
- Change in PASI-50(baseline and week 12)
- Proportion of subjects (≥ 2 grade change) on IGA scale(week 12)
研究者
研究点 (38)
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