EUCTR2010-019543-19-HU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
适应症
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
相似试验
进行中（未招募）
1 期
Placebo-controlled Trial of Pembrolizumab in Esophageal Carcinoma Participants Receiving Concurrent dCRTEsophageal CarcinomaMedDRA version: 21.0Level: LLTClassification code 10015366Term: Esophageal carcinomaSystem Organ Class: 100000004864EUCTR2019-002006-51-DKMerck Sharp & Dohme LLC600
进行中（未招募）
1 期
A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy in Participants with Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)imited-Stage Small Cell Lung Cancer (LS-SCLC)MedDRA version: 21.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 100000004864EUCTR2019-003616-31-PTMerck Sharp & Dohme LLC672
进行中（未招募）
不适用
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients with Previously Treated Indolent Non-Hodgkin LymphomaIndolent Non-Hodgkin Lymphoma (iNHL)MedDRA version: 14.1Level: HLTClassification code 10029621Term: Non-Hodgkin's lymphomas unspecified histology indolentSystem Organ Class: 100000004851EUCTR2013-003093-27-ESJanssen-Cilag International NV400
进行中（未招募）
不适用
Brodalumab in Subjects with Psoriatic ArthritisPsoriatic ArthritisEUCTR2013-003554-25-GBAmgen Inc.630
进行中（未招募）
1 期
A Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic CancerPatients with metastatic adenocarcinoma of the pancreas who have not received prior therapy for their metastatic diseaseMedDRA version: 20.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2014-004572-34-DEMerrimack Pharmaceuticals, Inc.91