A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of XmAb27564 in Patients With Plaque Psoriasis and Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Xencor, Inc.
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of XmAb27564 following multiple doses among participants with plaque psoriasis and atopic dermatitis.
详细描述
This is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study of XmAb27564. It is planned to enroll approximately 48 adult patients with mild-to-severe plaque psoriasis and 80 adult patients with moderate-to-severe atopic dermatitis. All patients will receive a total of 4 doses of study drug or placebo, administered subcutaneously every 2 weeks. A one year, open-label extension is available to qualifying patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion and exclusion criteria include, but are not limited to, the following:
- •Have active mild-to-severe plaque psoriasis or moderate-to-severe atopic dermatitis according to study-specific criteria
- •Weight between 40 to 150 kg, inclusive
- •No topical treatments for psoriasis or atopic dermatitis for 2 weeks before randomization
- •No phototherapy for psoriasis for 4 weeks before randomization
- •Washout of oral treatments for psoriasis or atopic dermatitis for 4 weeks before randomization
- •Washout of biologic treatments for psoriasis or atopic dermatitis for 12 weeks before randomization
- •Stated willingness to comply with all study procedures (including skin biopsies) and availability for the duration of the study
排除标准
- •Patients with a history of active asthma within 5 years of screening, except those that have well controlled asthma symptoms at screening visit.
- •Patients who have had any prior investigational treatment with IL-2 therapies
研究组 & 干预措施
Plaque Psoriasis
干预措施: XmAb27564 (Biological)
Plaque Psoriasis
干预措施: Placebo (Biological)
Atopic Dermatitis
干预措施: XmAb27564 (Biological)
Atopic Dermatitis
干预措施: Placebo (Biological)
结局指标
主要结局
To evaluate the safety and tolerability of multiple ascending dose subcutaneous (SC ) administration of XmAb27564
时间窗: Day 57
Safety and tolerability will be assessed by incidence of AE's; incidence of clinically significant changes in physical exams, vital signs, ECGs, and clinical laboratory testing; incidence of DLT's
次要结局
- To characterize pharmacokinetics(Day 57)
- To characterize pharmacodynamics(Day 57)