NCT06940700尚未招募2 期
To Evaluate the Efficacy and Safety of SHR-4597 Inhalants in Adults With Asthma: a Multicenter, Randomized, Open-label, Positive-controlled Phase II Clinical Study
Guangdong Hengrui Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in FEV1 (Pre-BD) from baseline
研究概览
简要总结
To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and ≤75 years old, gender is not limited;
- •Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
- •Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
- •Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
- •FEV1 during the screening period and before bronchodilator inhalation at baseline accounted for ≥40% and < 80% of the estimated value;
- •Screening and baseline visit, Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5;
- •FeNO values at screening period and baseline ≥25 ppb;
- •Patients with asthma who were treated for the first time or who had previously taken irregular medication were selected; Among them, the definition of irregular past use was: patients did not regularly use asthma control drugs within the first 3 months of enrollment, and the average weekly use compliance was < 50%.
- •A fertile female subject or a male subject whose partner is a fertile female must agree not to have a family plan and to voluntarily use highly effective contraception (including the partner) from the time of signing the informed consent until 1 month after the last study drug administration, and refrain from sperm/egg donation;
- •Voluntarily sign informed consent to participate in this study.
- •The subjects were unable to complete the questionnaires due to their limited educational level, or neither the subjects themselves nor their families could fill in the subject log card.
- •The researchers determined that there were other circumstances that were not suitable for participation in this study.
排除标准
- •Combined diseases or conditions
- •Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);
- •Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- •Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;
- •A history of infection requiring clinical intervention within 4 weeks prior to randomization, including but not limited to respiratory infection;
- •⑥ Known presence of parasitic infection within 6 months prior to randomization;
- •⑦ Blood donation or significant blood loss (≥400ml), or transfusion of blood products or immunoglobulin within 4 weeks prior to randomization;
- •⑧ A history of life-threatening acute asthma attacks (including admission to the intensive care unit and/or the need for invasive ventilator support [intubation/tracheotomy]);
- •⑨ History of acute asthma attack in the 4 weeks prior to randomization.
- •Combination of medication or treatment
- •Receiving non-selective beta-blockers (e.g., propranolol) within 1 week prior to screening;
- •Live attenuated vaccine or recombinant vaccine with viral vector were received within 4 weeks before randomization;
- •Receiving allergen immunotherapy 8 weeks before randomization;
- •Within 12 weeks before randomization or within 5 half-lives of the drug (refer to the drug instructions, whichever is older; For those with unknown half-lives, the first 12 weeks of randomization will be the use of systemic immunosuppressants (except for systemic glucocorticoids for asthma treatment, and systemic glucocorticoids for other conditions <3 days) or immunomodulators, or biologics or Th2 cytokine inhibitors, Including but not limited to methotrexate, cyclosporine, interferon-alpha, anti-IL-5 monoclonal antibody,anti-TSLP monoclonal antibody, anti-IGE monoclonal antibody, mesulast, etc.
- •Receiving a single dose of long-acting β2 agonist within 4 weeks prior to screening; ⑥4 weeks before randomization, inhaled corticosteroids (>500 micrograms of beclomethasone dipropionate per day [BDP] or equivalent dose);
- •⑦4 weeks before randomization, systemic glucocorticoid therapy;
- •Received bronchial thermoplasty or bronchial cryoablation within 1 year before randomization; ⑨There is a surgical plan during the study, or other treatment that the investigator believes may affect the evaluation of the subject;
- •Laboratory examination
- •①Significant abnormalities during screening or baseline laboratory tests:
- •White blood cell (WBC) < 3.0×109/L;
- •Blood eosinophils >1500cells/μL (1.5×109/L)
- •Hemoglobin (Hb) ≤90 g/L;
- •Alanine aminotransferase (ALT) > 3×ULN (upper limit of normal);
- •Aspartate aminotransferase (AST) > 3×ULN;
- •Total bilirubin (TBIL) > 1.5×ULN;
- •Prothrombin time (PT) > ULN+3s;
- •Creatinine (Cr) > 1.5×ULN;
- •Co-active hepatitis B (peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥1×103 IU[or copy] / mL), or hepatitis C antibody positive, or human immunodeficiency virus (HIV) positive, or treponema pallidum antibody positive.
- •Prolonged ECG QTc interval (>450ms) or other clinically significant abnormal results that may pose significant safety risks to subjects during the screening period;
- •General situation
- •Smoking or smoking cessation less than 6 months during the screening period, or previous smoking ≥10 pack years (pack years = number of years of smoking × number of packs per day); ②A history of drug use, alcohol abuse (average weekly consumption of ≥14 units of alcohol: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine) or drug abuse in the year prior to screening;
- •Have participated in other clinical studies and used investigational drugs containing active ingredients within 30 days prior to screening, or have been within 5 half-lives of investigational drugs at the time of screening (whichever is older);
- •Subjects who are pregnant (screening or baseline blood pregnancy test positive) or who plan to become pregnant while breastfeeding or during the study; ⑥Other reasons deemed unsuitable for study participation by the researcher.
- •Excessive alcohol consumption and drug abuse were prohibited throughout the study period (the definition of excessive alcohol consumption is the same as exclusion criterion IV.2).
- •Smoking (including e-cigarettes) was prohibited throughout the study period.
研究组 & 干预措施
Treatment group C
Active Comparator
Budesonide inhalant
干预措施: Budesonide inhalant (Drug)
Treatment group A
Experimental
SHR4597
干预措施: SHR4597 (Drug)
Treatment group B
Experimental
SHR4597
干预措施: SHR4597 (Drug)
结局指标
主要结局
Changes in FEV1 (Pre-BD) from baseline
时间窗: 6 weeks
次要结局
- Changes in FEV1 before bronchodilator (Pre-BD) administration compared with baseline at week 42(at week 42)
- Changes in forced vital capacity (FVC) before bronchodilator (Pre-BD) use compared with baseline at week 42(at week 42)
- Changes in peak expiratory flow (PEF) before bronchodilator (Pre-BD) use compared with baseline at week 42(at week 42)
- Changes in exhaled nitric oxide (FeNO) from baseline at 42 weeks(at 42 weeks)
- Changes in Asthma Control Questionnaire (ACQ-6) scores from baseline at 42 weeks(at 42 weeks)
- Change in mean number of nightly awakenings from baseline over 42 weeks(42 weeks)
- Changes in ACT questionnaire scores from baseline at 42 weeks(at 42 weeks)
研究者
研究点 (1)
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