NCT05507242招募中2 期
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
Asger Sverrild3 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2022年10月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation
研究概览
简要总结
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
详细描述
This is a multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD on LABA+LAMA±ICS with ≥ 1 exacerbation the past 12 months. Approximately 80 subjects will be randomized to receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 20-week treatment period.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •A diagnosis of COPD (according to GOLD (GOLD 2021 Report))
- •≥ 10 packyears smoked (current or ex-smokers)
- •Age 40 years or older
- •Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and < 80% predicted
- •Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1
- •≥1 prednisolon and/or antibiotic treated exacerbation in the past 12 months
- •Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff)
- •Subjects must demonstrate ≥ 70% compliance with daily inhalers during the screening/run-in
- •Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions through Week 20 of the study; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).
排除标准
- •Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.
- •Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis).
- •Current asthma
- •Lung volume reduction surgery for COPD
- •Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1 or during the run-in period
- •Any use of home oxygen therapy
- •Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study
- •History of cancer: Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit
- •Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit
- •Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to Visit 1 or during the screening period
- •A positive human immunodeficiency virus (HIV) test at screening or subject taking antiretroviral medications, as determined by medical history
- •Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
- •History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor contraindicates their participation.
- •History of any known primary immunodeficiency disorder excluding asymptomatic selective immunoglobulin A or IgG subclass deficiency.
- •Active tuberculosis or history of untreated latent tuberculosis
- •History of anaphylaxis to any biologic therapy.
- •Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months prior to Visit
- •Receipt of any of the following within 30 days prior to Visit 1: immunoglobulin or blood products, or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives prior Visit 1, whichever is longer.
- •Receipt of any marketed or investigational biologic agent within 4 months or 5 half- lives prior to Visit 1, whichever is longer.
- •Pregnant, breastfeeding or lactating females
- •History of chronic alcohol or drug abuse within 12 months prior to Visit
- •Planned surgical procedures requiring general anesthesia or in-patient status for > 1 day during the conduct of the study.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Concurrent enrollment in another clinical study involving an investigational treatment.
- •Receipt of any live or attenuated vaccines within 15 days prior to Visit 1.
结局指标
主要结局
To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation
时间窗: 20 weeks
The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20
次要结局
- To evaluate the effect of tezepelumab on mast cell bronchial mucosal tissue inflammation(20 weeks)
- To evaluate the effect of tezepelumab on macrophage cell bronchial mucosal tissue inflammation(20 weeks)
- To evaluate the effect of tezepelumab on neutrophilic bronchial mucosal tissue inflammation(20 weeks)
- To evaluate the effect of tezepelumab on CD4+ cell bronchial mucosal tissue inflammation(20 weeks)
- To evaluate the effect of tezepelumab on CD8+ cell bronchial mucosal tissue inflammation(20 weeks)
研究者
Asger Sverrild
MD, PhD, Clinical Associate Professor
Bispebjerg Hospital
研究点 (3)
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