NCT02087644撤回2 期
A Randomized, Placebo-Controlled, Phase IIb Study of CYT003-QbG10 (CYT003), a TLR9 Agonist, in Patients With Mild to Moderate Allergic Asthma Not Sufficiently Controlled on Inhaled Glucocorticosteroids
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Asthma Control Questionnaire (ACQ)
研究概览
简要总结
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma
详细描述
A phase IIb study in patients to evaluate CYT003- QbG10 versus placebo, in patients with mild to moderate allergic asthma not sufficiently controlled on inhaled steroid.
Altogether 170 patients, randomized to two treatment groups will be included. Key outcome measures are patient reported parameters on their asthma at the time of primary endpoint and throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Complete all protocol requirements.
- •Between 18 to 65 years of age.
- •Persistent allergic asthma patients
- •Forced expiratory volume in one second (FEV1) ≥60% to ≤ 90% of predicted value
- •Reversibility of airway obstruction
- •Patients meeting the contraception requirements
- •At baseline: Patients treated with ICS and insufficiently controlled
- •Blood eosinophil count above a certain level
排除标准
- •Failure to meet at least 80% compliance of use of the patient e-diary/ peak expiratory flow (PEF) meter (AM3 device) at the baseline visit
- •Treatment or hospitalization for asthma exacerbation within past 2 months
- •Current use or use of systemic corticosteroids within past 2 months
- •Current smokers.
- •Ex-smokers for less than 1 year, with a tobacco smoking history of >10 pack years
- •Major surgery within 3 months prior to signing the ICF or anticipated during study
- •Presence or history of clinically relevant cardiovascular, renal, pulmonary (e.g. COPD), endocrine, autoimmune, dermatological, neurological, psychiatric, or ocular disease as judged by the investigator.
- •Any malignancy within the previous 5 years
- •Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
- •Confirmed or suspected current infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- •Presence of active infectious disease as judged by the investigator
- •Active autoimmune diseases or prior diagnosis of autoimmune disease including but not limited to rheumatoid arthritis, lupus and ulcerative colitis.
- •Pregnancy (based on positive urine test at screening visit) or lactation.
- •Female planning to become pregnant during the study period.
- •Patients with any history of abuse of alcohol or other recreational drugs.
- •Ongoing or planned specific immunotherapy (SIT) during the whole study period or SIT completed within the last 3 years.
- •Use of investigational or approved biologics/immune-modulators within the last 6 months.
结局指标
主要结局
Asthma Control Questionnaire (ACQ)
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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