A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Parallel-group Study Evaluating the Efficacy and Safety of Golimumab Administered Subcutaneously in Symptomatic Subjects With Severe, Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The primary endpoint is the time to first severe asthma exacerbation through Week 24.
研究概览
简要总结
The purpose of this study is to assess the safety and effects (good and bad) of golimumab therapy in patients with severe, persistent asthma.
详细描述
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help treat this disease by blocking the activity of TNF in the body and reducing the symptoms of severe, persistent asthma.This study will assess the safety and effectiveness of subcutaneously (under the skin) administered golimumab and determine if there is a reduction of signs and symptoms in patients with active severe, persistent asthma. The effect of subcutaneously (SC) administered golimumab on the quality of life in patients with severe, persistent asthma will also be assessed. About 200 patients will take part in the study at approximately 60 centers worldwide. Participation in the study will last for about 42 weeks. The study consists of 3 phases: the screening phase (lasting between 1 and 4 weeks), the treatment phase (20 weeks), and the follow-up phase (20 weeks). Visits are scheduled to occur once every 4 weeks during the treatment and follow-up phases of the study. Patients eligible to take part in this study will be randomly placed into one of the following study groups: Group 1: Placebo (an inactive or dummy treatment that looks the same as the study drug, golimumab, but does not contain any active medication) from Week 0 through Week 20. Group 2: Golimumab 100 mg from Week 0 through Week 20. This study is "blinded." This means that neither patient nor study doctor will know in which group a patient is placed. However, if needed for safety or health reasons, the study doctor can find out a patient's study group at any time.
Patients will receive an injection (under the skin) of placebo (Group 1) or golimumab 100 mg (Group 2) every 4 weeks from Week 0 through Week 20.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Physician diagnosis of asthma for >= 3 years and a diagnosis of severe, persistent asthma for >= 1 year prior to screening
- •Reversible airway obstruction
- •Continuous treatment with high dose inhaled corticosteroids and long-acting Beta2-agonist for at least 3 months prior to screening
- •At least 1 occasion in the previous 6 months when worsening of asthma required treatment with additional steroids (intravenous or oral)
- •Score of >= 2 points on the Asthma Control Questionnaire (ACQ) at screening
排除标准
- •Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder
- •Life-threatening asthma attack requiring intubation in the 6-month period prior to screening
- •Steroid use at a dose > 20 mg of prednisone at the screening visit
- •Known malignancy or history of malignancy
- •Previous exposure to anti-TNF therapies
结局指标
主要结局
The primary endpoint is the time to first severe asthma exacerbation through Week 24.
时间窗: Week 24
次要结局
- Secondary endpoints include the number of severe asthma exacerbations through Week 24, number of clinically significant asthma exacerbations through Week 24, and change from baseline in Asthma Quality of Life Questionnaire (AQLQ) overall score at Week 24(Week 24)