A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
研究概览
简要总结
A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent.
- •Subjects aged 18-75 years.
- •Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.
- •Stable chronic mild-to-moderate plaque psoriasis.
排除标准
- •Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.
- •Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day
- •Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1
研究组 & 干预措施
DLX105-DMP Multi-Dose Twice Weekly
4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly
干预措施: DLX105-DMP (Drug)
DLX105-DMP Multi-Dose Once Weekly
4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly
干预措施: DLX105-DMP (Drug)
结局指标
主要结局
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
时间窗: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.
Local Tolerability Sensations
时间窗: Up to 4 Weeks
4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Local Site Application Assessment
时间窗: Up to 4 Weeks
Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles
Adverse Events
时间窗: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Treatment Emergent Adverse Events
Local Investigator Global Assessment (IGA)
时间窗: Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe
次要结局
- Pharmacokinetic Parameters(Day 1, Day 15, and Day 25)
- Immunogenicity Testing(Up to 4 Weeks after Last Dose)