2023-506000-50-00招募中2 期
A Phase 2a Randomised, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate to Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 42
- 主要终点
- Time to first CompEx (composite endpoint for exacerbation) event
研究概览
简要总结
To evaluate the clinical efficacy of AZD4604 1.4 mg BID as compared to placebo in adult participants with moderate-to-severe uncontrolled asthma.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age inclusive, at the time of signing the informed consent.
- •Male and/or female, Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. There are no restrictions on male participants or their female partners. At the end of the Run-in period (Visit 3), participants must fulfil the following additional criteria in order to be randomised into the study and enter the Treatment period:
- •Pre-BD FEV1 ≥ 40% (pre-randomisation)
- •A pre-BD/pre-IMP dose FEV1 at Visit 3 that has not increased or decreased by 20% or more from the pre-BD FEV1 recorded at Visit 1 and at Visit
- •An ACQ-6 score of ≥ 1.
- •At least 80% compliance with usual asthma background medication during Run-in period (from Visit 2 to Visit 3) based on the daily asthma ePROs.
- •Minimum 80% compliance with daily eCOAs (electronic Clinical Outcome Assessments) during the Run-in period and during the 14 days preceding Visit
- •6.'For FOCBP or female participants on HRT, a negative urine pregnancy test prior to administration of IMP (randomisation).
- •Treatment with additional asthma controller therapies (LAMA, LTRA) at a stable dose for ≥ 28 days prior to Visit 1 is allowed.
- •Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit
- •Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3 (pre-randomisation).
- •Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria.
- •Documented evidence of asthma in the 10 years up to or including Visit
- •A clinical diagnosis of asthma must be documented at least 12 months prior to Screening (Visit 1).
- •An ACQ-6 score ≥ 1.5 at Visit 1 and at Visit
- •Able and willing to comply with the requirements of the CSP including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at the study site, and use electronic devices, eg, ePRO device and spirometer
- •Body weight of ≥ 40 kg and body mass index of < 35 kg/m2
排除标准
- •A severe asthma exacerbation within 8 weeks prior to randomisation
- •Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the Follow-up period
- •Concurrent enrolment in another interventional clinical study
- •History of herpes zoster reactivation
- •Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product
- •Abnormal findings identified on physical examination, ECG, or laboratory testing
- •For female participants only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding
- •Current smokers or participants with smoking history ≥ 10 pack-years
- •Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons
- •Positive family history of lung cancer,in first degree relatives (mother, father, sisters, brothers and children).
- •Positive urine cotinine test or exhaled carbon monoxide test at Visit 1 and at any timepoint throughout the study
- •Current or prior history of alcohol or drug abuse (including marijuana), as judged by the investigator
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements
- •Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1
- •Participants with a significant COVID-19 illness within 6 months of enrollment
- •Clinically important pulmonary disease other than asthma
- •Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: -affect the safety of the participant throughout the study, -influence the findings of the study or the interpretation, or -impede the participant’s ability to complete the entire duration of study
- •Any clinically significant cardiac or cerebrovascular disease
- •History of venous thromboembolism
- •Participants who, as judged by the investigator, have evidence of active TB, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment
- •Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for HIV.
- •History of malignancy other than superficial basal cell carcinoma
- •Participant treated with any investigational drug within 4 months (or 5 half-lives,whichever is longer) prior to Visit
- •Treatment with systemic corticosteroid within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1
- •Any immunosuppressive therapy within 12 weeks prior to Visit 1
- •Treatment with marketed biologics within 6 months of Visit 1 or 5 half-lives, whichever is longer
- •Inhaled corticosteroid plus fast-acting β2 agonist as a reliever is not allowed 15 days prior to Visit 1, during Screening/Run-in and throughout the Treatment period and preferably 1 week after the last dose of IMP
- •Live, attenuated, or mRNA vaccines within 4 weeks of Visit
- •Immunoglobulin or blood products within 4 weeks of Visit 1
结局指标
主要结局
Time to first CompEx (composite endpoint for exacerbation) event
Time to first CompEx (composite endpoint for exacerbation) event
次要结局
- Change from baseline in: 1 Pre-BD FEV1 at Week 4 and Week 12
- CAAT at Week 4 and Week 12
- ACQ-6 at Week 4 and Week 12
- Average morning and average evening PEF at Week 4 and Week 12, and average over the 12-week Treatment period
- Daily asthma symptom score (total, daytime, and night-time) at Week 4 and Week 12
研究者
Astrazeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (42)
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