A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Safety as assessed by the incidence and severity of adverse events
研究概览
简要总结
This is a study to determine the safety of multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.
详细描述
The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines.
There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.
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
- •Males and females, 18 - 75 years old.
- •Diagnosis of chronic spontaneous urticaria (CSU) despite the use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists, as defined by:
- •Diagnosis of CSU for >/= 6 months.
- •The presence of itch and hives for >/= 6 consecutive weeks at any time prior to Visit 1 despite current use of H1-antihistamines.
- •UAS7 of >/= 16 and HSS7 of >/= 8 during the 7 days before treatment
- •In-clinic UAS >/= 4 on one of the screening visit days
- •Use of H1-antihistamines alone or in combination with H2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study.
- •Other than CSU, have no other significant medical conditions that would cause additional risk or interfere with study procedures.
- •Normal blood counts and liver function tests.
- •Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment.
- •Willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule.
排除标准
- •Women who are pregnant or nursing.
- •Cleary defined cause for chronic urticaria.
- •Known HIV, hepatitis B or hepatitis C infection.
- •Vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza for injection.
- •History of anaphylaxis.
- •There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
研究组 & 干预措施
CDX-0159
CDX-0159 every 4-8 weeks
干预措施: CDX-0159 (Drug)
Normal Saline
Normal saline every 4-8 weeks
干预措施: Normal Saline (Drug)
结局指标
主要结局
Safety as assessed by the incidence and severity of adverse events
时间窗: From Day 1 (first dose) to Day 169 (last follow-up visit)
Safety of multiple, ascending doses of CDX-0159 as determined by drug related adverse events
次要结局
- Pharmacokinetic evaluation(From Day 1 (before first dose) to Day 169 (last follow-up visit))
- Pharmacodynamic evaluation(From Day 1 (before first dose) to Day 169 (last follow-up visit))
- Safety evaluation(From Day 1 (before dosing) to Day 169 (last follow-up visit))