2024-517457-27-00招募中3 期
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (JOURNEY)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 69
- 主要终点
- Annualised rate of moderate or severe COPD exacerbations up to 76 weeks
研究概览
简要总结
To compare the effect of tezepelumab with placebo on moderate or severe COPD exacerbations in participants with moderate to very severe COPD
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult participants 40 to 80 years of age at the time of signing the informed consent.
- •Documented physician-diagnosed COPD for at least 12 months before Visit
- •A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 ≥ 20% and ≤ 70% of the predicted normal valueduring screening.
- •Documented regular dose of triple (ICS+LABA+LAMA) or dual (LABA+LAMA, ICS+LABA,ICS+LAMA) inhaled therapy for at least 3 consecutive months before Visit
- •Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit
- •At least 1 of the 2 moderate exacerbations must have been treated with SCS.
- •EOS ≥ 150 cells/μL during the screening period.
- •CAT total score ≥ 15 at Visit
- •Current or former smokers (with smoking cessation ≥ 6 months before Visit 1) have a history of atleast 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year).
排除标准
- •Clinically important lung disease other than COPD (eg, active lung infection, clinically significantbronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated withobesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or anotherdiagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg,allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis,hypereosinophilic syndrome).
- •LTOT with signs and/or symptoms of cor pulmonale and/or right ventricular failure, or LTOT > 4.0litres/minute (L/min) at rest or an oxyhaemoglobin saturation < 89% despite LTOT.
- •Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use ofnon-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.
- •Maintenance treatment with macrolides or other antibiotics for COPD if the duration of thetreatment is < 6 consecutive months before Visit
- •Radiological findings suggestive of a respiratory disease other than COPD that is significantlycontributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACR Lung-RADS v2022, (Christensen etal 2024)) without appropriate follow up before Visit
- •Radiological findings suggestive of acute infection.
- •Current physician diagnosed asthma according to the Global Initiative for Asthma (GINA 2024 andonwards versions) guidelines or other accepted guidelines, past physician diagnosed asthmaincluding paediatric asthma, or asthma-COPD overlap syndrome.
- •Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal,neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immune,psychiatric, or major physical/or cognitive impairment that is not stable in the opinion of theinvestigator or the sponsor and/or could: − Affect the safety of the participant throughout the study − Influence the findings of the study or their interpretation − Impede the participant’s ability to complete the entire duration of the study and/or comply withthe study visit schedule and procedures
- •Unstable cardiovascular disorder (including but not limited to ischemic heart disease, arrhythmia,cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure, uncontrolledhypertension, as defined by the Investigator, or any other relevant cardiovascular disorder or ECGabnormality that in the Investigator’s judgment may put the participant at risk or negatively affectthe outcome of the study.
- •Tuberculosis requiring treatment in the last 12 months before Visit
- •Malignancy, current or past (within 5 years before Visit 1), except for basal cell carcinoma, localisedsquamous cell carcinoma of the skin, or in situ carcinoma of the cervix provided when a curativetherapy was completed at least 12 months before Visit
- •Treatment with systemic immunosuppressive/immunomodulating medications includingmaintenance use of SCS within the last 12 weeks or 5 half-lives before Visit 1 or during thescreening for other reasons than COPD exacerbation. Expected need for chronic use during thestudy for any reason.
结局指标
主要结局
Annualised rate of moderate or severe COPD exacerbations up to 76 weeks
Annualised rate of moderate or severe COPD exacerbations up to 76 weeks
次要结局
- 1. Change from baseline in pre-BD FEV1 at Week 52
- 2. Change from baseline in the SGRQ total score over 52 weeks
- 3. Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants withscreening EOS ≥ 300 cells/μL
- 4. Annualised rate of severe COPD exacerbations up to 76 weeks
- 5. Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks
- 6. Change from baseline in the CAT total score over 52 weeks
- 7. Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-pointscore decrease) over 52 weeks
- 8. Time to first moderate to severe COPD exacerbation up to 76 weeks
- 9. Time to first severe COPD exacerbation up to 76 weeks
- 10. Change from baseline in post-BD FEV1 at Week 52
- 11. PK: Serum trough concentrations
- 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies
研究者
AZ Clinical Study Info Center
Scientific
AstraZeneca AB
研究点 (69)
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