2023-503571-19-00已完成3 期
A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (Oberon)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 71
- 主要终点
- Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
研究概览
简要总结
To evaluate the effect of 2 dose regimens of tozorakimab as addon to standard of care compared with standard of care plus placebo on the rate of moderate to severe exacerbations in former smokers.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 40 years of age and capable of giving signed informed consent.
- •Documented diagnosis of COPD for at least one year prior to enrolment.
- •Post BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value.
- •Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
- •Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment.
- •Smoking history of ≥ 10 pack-years.
- •CAT total score ≥ 10, with each of the phlegm (sputum) and cough items with a score ≥ 2
排除标准
- •Clinically important pulmonary disease other than COPD.
- •Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
- •Significant COVID-19 illness within the 6 months prior to enrolment.
- •History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C)
- •Unstable cardiovascular disorder.
- •Participants who have evidence of active TB.
- •History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV
- •Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
- •Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant’s ability to complete the entire duration of the study.
- •Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.
- •Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidances, without appropriate follow up prior to randomisation. Radiological findings suggestive of acute infection.
- •Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of
- •Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms.
- •Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study.
- •COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization.
- •Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection.
- •Participants that have previously received tozorakimab.
- •Evidence of active liver disease, including jaundice during screening.
研究组 & 干预措施
Tozorakimab-placebo
Placebo
干预措施: Tozorakimab-placebo (Drug)
Tozorakimab
Test
干预措施: Tozorakimab (Drug)
SALBUTAMOL
Auxiliary
干预措施: SALBUTAMOL (Drug)
结局指标
主要结局
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
次要结局
未报告次要终点
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (71)
Loading locations...
相似试验
已完成
3 期
Study to assess efficacy, safety, and tolerability of Tozorakimab in patients with symptomatic chronic obstructive pulmonary disease (COPD) with a history of exacerbations.2023-503572-24-00AstraZeneca AB350
招募中
3 期
A Study to evaluate the long-term safety and tolerability of tozorakimab in patients with chronic obstructive pulmonary disease (COPD) and a history of exacerbations.2025-523690-41-00AstraZeneca AB82
招募中
3 期
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (TILIA).2023-507031-38-00Astrazeneca AB828
招募中
2 期
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer2023-504027-78-00F. Hoffmann-La Roche AG150
招募中
3 期
A Randomized, Double-Blind, Placebo-Controlled, MultiRegional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004/TAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy2023-507097-41-01Shanghai Junshi Biosciences Co. Ltd.149