EUCTR2010-019543-19-AT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Determine the Safety and Efficacy of AMG 827 in Subjects wth Inadequately Controlled Asthma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men or women 18 to 65 years of age at the time of screening
- •- Percent of predicted FEV1 = 50% and = 80% at screening and baseline visits
- •- At least 12% reversibility over pre-bronchodilator FEV1 with SABA
- •inhalation (up to 8 puffs) or nebulized equivalent (up to 2 treatments with
- •2.5 mg albuterol), demonstrated in the office during screening
- •- Inhaled corticosteroid (ICS) = 200 and = 1000 µg/day fluticasone or
- •equivalent. Stable ICS dose for = 30 days before screening and must
- •have used ICS for at least the last 3 consecutive months before
- •screening. The ICS dose is expected to remain the same from screening
- •through the end of study.
- •- Ongoing asthma symptoms with ACQ composite score = 1.5 points at
- •screening and baseline
- •- If receiving allergen immunotherapy, a stable dose for > 3 months before
- •screening and anticipated to remain stable for the duration of the study
- •- Nonsmoker or ex-smoker with < 10 pack-years (eg, 1 pack per day for 10
- •years) who stopped = 1 year ago
- •- Subject has a negative purified protein derivative (tuberculin) skin test
- •within 6 weeks prior to randomization and has not been exposed to a
- •person with active tuberculosis within 6 months of screening. Subjects
- •with a known positive tuberculin skin test are allowed if:
- •They have completed treatment with appropriate chemoprophylaxis,
- •They have a history of Bacillus Calmette-Guerin vaccination with a
- •negative Quantiferon test
- •- Subject or subject’s legally acceptable representative has provided
- •informed consent, before any study specific procedure
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Acute asthma exacerbation requiring emergency room treatment or
- •hospitalization within 2 months of screening or any exacerbation between
- •screening and baseline
- •- Respiratory infection within 4 weeks of screening visit or 1 week of
- •baseline visit
- •- Any evidence of active infection at screening, during the run-in period or
- •at the baseline visit requiring systemic antibiotics
- •- History of endotracheal intubation for asthma-related exacerbation within
- •3 years of screening
- •- History of chronic obstructive pulmonary disease or other chronic
- •pulmonary condition other than asthma
- •- Current diagnosis of sleep apnea with ongoing symptoms or requiring
- •continuous positive airway pressure
- •- History of aspirin-sensitive asthma
- •- Any uncontrolled or clinically significant systemic disease (eg,
- •uncontrolled diabetes, liver disease)
- •- Any finding on the screening ECG that in the opinion of the investigator
- •requires further cardiovascular evaluation
- •- Poorly controlled hypertension defined as resting blood pressure
- •> 150/90 mmHg (assessed on 2 separate occasions during the screening
- •- Malignancy (other than resected cutaneous basal or cutaneous squamous
- •cell carcinoma, or treated in situ cervical cancer considered cured) within
- •5 years of screening visit (if a malignancy occurred > 5 years ago, subject
- •is eligible with documentation of disease-free state since treatment)
- •- Known to have tested positive for hepatitis B virus surface antigen,
- •hepatitis C virus antibody or human immunodeficiency virus
- •- Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, or up to 10 weeks after the last dose of study drug.
研究者
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