A Phase 1b Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study Assessing the PK, Pharmacodynamics, Safety, and Tolerability of SB414 in Subjects With Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novan, Inc.
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Plasma concentrations of hMAP3
研究概览
简要总结
The objectives of this study are to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of SB414 in subjects with mild to moderate plaque psoriasis.
详细描述
This is a phase 1b, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 36 adult subjects with mild to moderate chronic plaque psoriasis. After obtaining informed consent, subjects will be randomized to active or vehicle treatment arms. Subjects will apply the study product (SB414 6% or Vehicle cream) twice daily to all affected areas of psoriasis on the trunk and/or extremities for 4 weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female, 18-70 years old, and in good general health;
- •Have a clinical diagnosis of stable chronic plaque psoriasis of mild to moderate severity based on the PSGA, involving 2-15% BSA (excluding the scalp/face), present for > 6 months;
- •Must have at least 2 target plaques on trunk and/or extremities at least 5 cm2 with a TPSS > 5 and thickness sub-score >
- •Target plaques cannot be located on the groin, hands, feet, neck, face, elbows, knees, ankles or scalp;
- •Be willing to not use any other systemic agents used to treat psoriasis or apply any other topical products (medicated or over-the-counter) to the treatment sites on the trunk and/or extremities during the study;
- •Women of childbearing potential (WOCBP) must have a negative UPT prior to randomization and must agree to use an effective method of birth control during the study and for 30 days after their final study visit.
排除标准
- •Have inverse (i.e.: axillae, groin) or facial psoriasis only, erythrodermic psoriasis, guttate psoriasis, pustular psoriasis, drug-induced psoriasis, and /or psoriatic arthritis requiring treatment with disease modifying antirheumatic drugs (DMARDs);
- •Concurrent or recent use of topical or systemic medications without a sufficient washout period;
- •Are immunocompromised, including those who are known HIV positive or received immunosuppressive treatment within the past 6 months;
- •Female subjects who are pregnant, nursing mothers, or planning to become pregnant during the study.
研究组 & 干预措施
SB414 6%
SB414 6% topically twice daily
干预措施: SB414 6% (Drug)
Vehicle Cream
Vehicle Cream topically twice daily
干预措施: Vehicle (Drug)
结局指标
主要结局
Plasma concentrations of hMAP3
时间窗: Day 29
Peak plasma concentrations of hMAP3 after topical application of SB414
次要结局
- Safety Profile (Reported Adverse Events)(Day 29)
- Subject Assessment of Tolerability(Baseline, Week 2 and Week 4)
- Efficacy Assessed by Target Plaque Severity Score (TPSS)(Baseline, Week 2 and Week 4)
- Pharmacodynamics of SB414(Day 29)
- Efficacy Assessed by Physician's Static Global Assessment(Screening, Baseline, Week 2 and Week 4)
- Efficacy as assessed by Itch Numeric Rating Scale (NRS)(Screening, Baseline, Week 2 and Week 4)