NCT00983658已完成2 期
A Phase II, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous huMAb OX40L (RO4989991) in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
研究概览
简要总结
This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by IV infusion for the treatment of allergen-induced asthma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight between 50 and 125 kg
- •Mild, stable allergic asthma
- •History of episodic wheeze and shortness of breath
- •FEV1 at baseline ≥ 70% of the predicted value
- •For women of childbearing potential, agreement to use an effective means of contraception while enrolled in the study
- •For men with partners of childbearing potential, willingness to use condoms with spermicide during treatment
- •Ability to comprehend and follow all required study procedures
- •Positive skin prick test to common aeroallergens (e.g., cat, dust, mite, grass, and pollen)
- •Positive allergen-induced early and late airway bronchoconstriction
排除标准
- •A worsening of asthma or a respiratory tract infection within 6 weeks preceding study entry
- •Acute infection (including viral infection) within the 6 weeks preceding dosing (8 weeks for respiratory infections) or any ongoing chronic infection
- •History of recurrent bacterial infection as an adult or history or presence of any chronic infectious condition, including (but not limited to), tuberculosis, parasitic infection, etc.
- •Lung disease other than mild allergic asthma
- •History of heart, lung, kidney, liver, neurologic or chronic infectious disease
- •Concomitant disease or condition, which could interfere with the conduct of the study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease
- •History of serious adverse reaction or hypersensitivity to any drug
- •Pregnancy or lactation or positive serum pregnancy test at screening
- •Chronic use of any other medication for treatment of allergic lung disease other than short-acting β2-agonists or ipratropium bromide
- •Current (or history of) treatment with a monoclonal antibody or chimeric biomolecule within the past 5 months (5 half-lives of the drug), including omalizumab
- •Regular use of tobacco products of any kind or within the previous 6 months, or smoking history > 10 pack-years
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: placebo (Drug)
huMAb OX40L
Experimental
干预措施: huMAb OX40L (Drug)
结局指标
主要结局
The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo
时间窗: 16 weeks after the first dose
次要结局
- LAR after the allergen challenge in patients treated with huMAb OX40L versus placebo(Approximately Day 56 prior to third dose)
- Change in methacholine challenge response relative to the pre-allergen challenge PC20(24 hours after each allergen challenge)
- Early asthmatic response (EAR) in patients treated with huMAb OX40L versus placebo(Between 0 and 2 hours after each allergen challenge)
- Incidence and nature of treatment-emergent adverse events(Through study completion or early study discontinuation)
- Incidence and nature of infusion reactions(Through study completion or early study discontinuation)
- Incidence of infectious complications(Through study completion or early study discontinuation)
- Incidence, nature, relatedness, and severity of adverse events(Through study completion or early study discontinuation)
- Clinically significant changes in vital signs, electrocardiograms, FEV1, and safety laboratory measures(Through study completion or early study discontinuation)
- Incidence of anti-therapeutic antibodies(Through study completion or early study discontinuation)
研究者
相似试验
已完成
2 期
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic AlopeciaMale Pattern Hair LossAlopeciaNCT05218642Suzhou Kintor Pharmaceutical Inc,123
终止
2 期
A Study to Evaluate the Safety and Efficacy of Basmisanil in Adults With Severe Motor Impairment Following an Ischemic StrokeStrokeNCT02928393Hoffmann-La Roche5
已完成
2 期
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01397578Genentech, Inc.91
已完成
2 期
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)Alzheimer's DiseaseNCT01343966Genentech, Inc.448
已完成
2 期
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)Depressive DisorderDepressive SymptomsDepressive Disorder, MajorDepressive EpisodeDepression SevereDepressionNCT05686408Tonix Pharmaceuticals, Inc.132