CTRI/2017/10/010093已完成3 期
Prospective, multi-center, randomized, double-blind,two-arm, parallel group, active control, comparativeclinical study to evaluate efficacy and safety of R-TPR-022 / Xolair® in patients with moderate to severepersistent asthma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- The primary efficacy endpoint will be the incidence of clinically significant asthma exacerbations after first study dose administration till week 16.
研究概览
简要总结
This is a prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-022 / Xolair® in patients with moderate to severe persistent asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females patients of ≥18-65 years of age, inclusive.
- •Patient with the diagnosis of moderate to severe persistent asthma >1 year duration.
- •Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
- •Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires.
- •Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication.
- •Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
排除标准
- •Any Clinically significant abnormal laboratory investigations or physical examination findings which may pose risk to the patients as assessed by investigator at screening visit.
- •Prior Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening Visit.
- •Patient with history of near fatal or life-threatening (including intubation) asthma within the past year prior to screening visit.
- •Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Omalizumab or its any excipients. History of illicit drug use within one year prior to randomization.
- •Prior use of Omalizumab.
- •Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.
- •Significant, non-reversible, active pulmonary disease.
- •Current smoker or smoking history within 12 months prior to the Screening Visit.
- •Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication; Clinically significant peripheral vascular disease; Uncontrolled diabetes; Serious active or uncontrolled infection.
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- •Inability to comply with study and/or follow-up procedures.
- •Subjects with HIV, HBsAg, HCV test positive.
- •History or presence of any form of cancer within the 10 years prior to randomization.
- •Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study.
- •History or presence of any medical or psychiatric condition or disease, or laboratory abnormality or any other condition that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study.
- •Participation in any clinical study of an investigational product within the previous 3 months.
结局指标
主要结局
The primary efficacy endpoint will be the incidence of clinically significant asthma exacerbations after first study dose administration till week 16.
时间窗: Week 16
次要结局
- PK and PD (free and total IgE) assessments(First sample (pre-dose) will be collected within 1 hour prior to drug administration)
研究者
研究点 (11)
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