NCT05072886进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Topical AT193 in the Treatment of Patients With Nail Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nail psoriasis for at least 3 months preceding study entry
- •Diagnosis or history of plaque psoriasis or psoriatic arthritis
- •A female participant of childbearing potential must use appropriate contraceptive measures during the study period
- •A female participant of childbearing potential must have a negative urine pregnancy test result at screening
- •Written informed consent must be obtained before any study procedure is performed
排除标准
- •Pregnant or breastfeeding
- •Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis
- •History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator
研究组 & 干预措施
AT193
Experimental
Topical applied daily
干预措施: AT193 (Drug)
Placebo
Placebo Comparator
Topical applied daily
干预措施: AT193 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A First-in-Human Study of QY211 Gel in Adult SubjectsAtopic DermatitisNCT05843422E-nitiate Biopharmaceuticals (Hangzhou) Co., Ltd.56
终止
1 期
Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis SubjectsHealthyRheumatoid ArthritisNCT01962337Five Prime Therapeutics, Inc.66
招募中
1 期
A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants With ALSAmyotrophic Lateral SclerosisNCT05279755ProJenX72
已完成
1 期
Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy VolunteersHealthy VolunteersNCT05663593Haisco Pharmaceutical Group Co., Ltd.74
终止
1 期
Safety, Tolerability and Pharmacodynamics of SYNB1020CirrhosisNCT03447730Synlogic23