NCT03448081已完成2 期
An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment
Sienna Biopharmaceuticals20 个研究点 分布在 2 个国家目标入组 73 人开始时间: 2018年2月12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
- 73
- 试验地点
- 20
- 主要终点
- Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
研究概览
简要总结
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
详细描述
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
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
- •Written informed consent
- •Stable psoriasis for at least 6 months prior to screening
- •Chronic pruritus of the psoriasis plaques at least 6 weeks prior to screening
- •At least moderate baseline overall itch associated with psoriatic plaques
- •Willing and able to undergo a 4-week run-in with calcipotriene ointment dosing and remain on this stable regimen throughout the study
- •Mild or moderate psoriasis at screening and baseline
- •Subject's plaques are amenable to treatment with a topical medication
- •Willing and able to discontinue all other topical products to treat psoriasis and/or itch, including topical steroids
- •Willing and able to avoid prolonged exposure of the designated treatment plaques to ultraviolet (UV) radiation (natural and artificial) for the duration of the study
- •Women of childbearing potential must have a negative pregnancy test and must agree to use highly effective methods of contraception during the study
- •Men who engage in sexual activity that can result in fathering 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
- •Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- •Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments
- •Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
- •Subjects with a clinical diagnosis of bacterial infection of the skin
- •Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene
- •Known hypersensitivity to SNA-120 (pegcantratinib), calcipotriene, the study treatment excipients, and /or polyethylene glycol (PEG), or a history of drug or other allergy that, in the opinion of the investigator, 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 or 5 half-lives of investigational drug (whichever is longer) of baseline
- •Women who are pregnant or lactating, or are planning to become pregnant during the study
- •Subjects previously participating in any SNA-120 (and/or CT327 or pegcantratinib) clinical studies
研究组 & 干预措施
SNA-120 + Calcipotriene
Active Comparator
干预措施: Calcipotriene (Drug)
Placebo + Calcipotriene
Placebo Comparator
干预措施: Placebo (Drug)
SNA-120 + Calcipotriene
Active Comparator
干预措施: SNA-120 (Drug)
Placebo + Calcipotriene
Placebo Comparator
干预措施: Calcipotriene (Drug)
结局指标
主要结局
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
时间窗: week 8
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
次要结局
- Change in Investigator Global Assessment (IGA) from baseline(week 8)
- Change in Psoriasis Area Severity Index (PASI) from baseline(week 8)
研究者
研究点 (20)
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