NCT01605708终止1 期
Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Dose Study of the Clinical Activity, Safety, Tolerability and Pharmacokinetics of a Single IV Dose of REGN846 in Refractory Moderate-to-Severe Pruritus in Adult Patients With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Clinical Activity
研究概览
简要总结
The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include, but are not limited to the following:
- •Men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
- •Patients must have applied a stable dose of an additive-free, basic, bland emollient twice daily for at least 7 days before the baseline visit
- •Chronic Atopic Dermatitis (AD)
- •Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- •Refractory pruritus for ≥ 6 weeks before screening. Pruritus should be associated only with AD and not with any other condition(s).
- •Itching associated with AD
排除标准
- •Exclusion criteria include, but are not limited to the following:
- •A history of listeriosis.
- •Presence of any 1 of the following tuberculosis (TB) criteria:
- •A history of active TB
- •A positive QuantiFERON TB test at the screening visit
- •Chest radiograph (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
- •Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
- •Any clinically significant physical abnormalities observed during the screening visit.
- •Diabetic, hypertensive, or any known atherosclerotic vascular disease.
- •Hospitalization for any reason within 60 days of the screening visit.
- •History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
- •History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
- •Known sensitivity to doxycycline or tetracycline.
- •Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
- •Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: REGN846 (Drug)
结局指标
主要结局
Clinical Activity
时间窗: Week 6
To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.
次要结局
- Immunogenicity of a single IV dose of REGN846(Week 1 - Week 6)
- Safety and tolerability a single IV dose of REGN846(Week 1 - Week 6)
- Pharmacokinetic (PK) profile of a single IV dose of REGN846(Week 1 - Week 6)
研究者
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