NCT06488755招募中3 期
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SIM0718 in Adults and Adolescents With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Annualized rate of severe asthma exacerbation events
研究概览
简要总结
Phase III clinical study of SIM0718 asthma
详细描述
A multicenter, randomized, double-blind, parallel-group, placebo-controlled phase III clinical study evaluating the efficacy and safety of SIM0718 in adults and adolescents with asthma
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 75 years, weight ≥ 40 kg, diagnosed with asthma for at least 12 months；
- •Currently receiving medium- to high-dose inhaled corticosteroids (ICS) in combination with 1 or 2 control medications and have been on a stable dose for at least 28 days prior to randomization；
- •Pre-bronchodilator (trough) FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents ；
- •Positive bronchodilator response within 12 months prior to randomization or during the screening period;
- •Asthma Control Questionnaire (ACQ-5) score ≥ 1.5;
- •At least one severe asthma exacerbation within 12 months prior to the screening visit and no occurrence within 28 days prior to randomization;
- •Based on the investigator judgment, the subject demonstrates acceptable inhaler, peak flow meter, and spirometry techniques;
- •Compliance with usual asthma controller use ≥ 80% based on the patient diary in 7 days prior to dosing;
- •Voluntarily participate in this clinical study and sign the informed consent form and be able to comply with the clinical visit schedule and study-related procedures;
- •Female subjects of childbearing potential who are sexually active with non-sterilized male partners, male subjects, and their female partners of childbearing potential agree to use adequate and effective contraception throughout the study;
排除标准
- •Current respiratory disease that may impair lung function as judged by the investigator;
- •Diagnosis of helminth parasitic infection within 24 weeks prior to randomization and who have not received or have not responded to standard therapy;
- •Within 28 days prior to randomization, with acute or chronic infection; or have a severe viral infection;
- •Has a known or suspected history of immunosuppression or frequent, recurrent, or long-term infection;
- •History of active tuberculosis; or untreated latent tuberculosis or tuberculosis not receiving standard treatment, unless the investigator judges that the patient has been adequately treated;
- •People with hepatitis B, hepatitis C, or HIV infection;
- •History of malignancy;
- •Major surgery within 8 weeks prior to signing the informed;
- •Bronchial thermoplasty within 12 months prior to randomization;
- •Treatment of systemic glucocorticoid during 4 weeks prior to signing informed to randomization;
- •Previous use or ongoing use of systemic immunosuppressants or biologics for the treatment of autoimmune or inflammatory diseases in 8 weeks or 5 half-lives prior to randomization;
- •Within 16 weeks or 5 half-lives prior to randomization, received a biologic agent with the same therapeutic purpose;
- •Participated in an interventional clinical trial of any drug or medical device within 3 months or 5 half-lives prior to randomization;
- •Poor response to or intolerance to prior anti-IL-4Rα antibody therapy;
- •Within 3 months prior to randomization, received specific immunotherapy；
- •Receipt of intravenous human immunoglobulin (IVIG) or blood products within 30 days prior to randomization;
- •Vaccination with live(attenuated) vaccine within 30 days prior to randomization or plan to receive live (attenuated) vaccine during the study;
- •Are using concomitant medications or treatments that are prohibited in the protocol;
- •The following laboratory abnormalities occurred during the screening period: eosinophils≥1500 cells/mm3 or 1.5×109/L; Platelets≤80,000 cells/mm3 or 80×109/L; phosphocreatine kinase (CPK) ≥5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≥3-fold ULN; aspartate aminotransferase (AST)≥ 3-fold ULN; Bilirubin ≥ 2x ULN;
- •History of alcohol abuse or drug abuse within 12 months prior to randomization;
- •Current smokers, or those who have been smoking in recent 6 months, or former smokers who have not been smoking for 6 months with a smoking history of ≥10 pack years;
- •Allergy to L-histidine, trehalose, or Tween 80, or history of systemic hypersensitivity to any biologic products;
- •Females of childbearing potential have a positive pregnancy test result during the screening period; Females planning to become pregnant or breastfeeding;
- •Any clinically significant examination abnormality or serious and/or uncontrolled disease that, in the opinion of the investigator, may affect the subject safety, or affect the evaluation of efficacy, or preclude the subject completion of the entire study.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: SIM0718 injection of placebo (Drug)
SIM0718 injection
Experimental
SIM0718 injection
干预措施: SIM0718 injection (Drug)
结局指标
主要结局
Annualized rate of severe asthma exacerbation events
时间窗: 52 weeks
Annualized rate of severe asthma exacerbation events within 52 weeks
次要结局
- Positive rate and titer of anti-drug antibodies, positive rate of neutralizing antibodies(64 weeks during the study)
- Change from baseline in forced expiratory volume in the first second before bronchodilator use(12 weeks)
- SIM0718 blood concentration(During the 52-week treatment period)
- Change from baseline in Forced Vital Capacity (FVC)(During the 52-week treatment period)
- Change from baseline in pre-bronchodilator forced expiratory volume in 1 second(During the 52-week treatment period)
- Adverse events(during the 64 week study period)
- Vital signs(during the 64 week study period)
- Electrocardiograph (12-ECG)(during the 64 week study period)
- Laboratory tests(during the 64 week study period)
- Change from baseline in Peak Expiratory Flow (PEF)(During the 52-week treatment period)
- Time from baseline to the first severe asthma exacerbation event, proportion of subjects with ≥ 1 severe asthma exacerbation(During the 52-week treatment period)
- Annualized rate of "loss of asthma control" events, time from baseline to "loss of asthma control"event(During the 52-week treatment period)
- Change from baseline in ASTHMA CONTROL QUESTIONNAIRE(ACQ-5) score(During the 52-week treatment period)
- Asthma symptom score(During the 52-week treatment period)
- Change from baseline in annualized rate of hospitalization or emergency department visits, utilization of medical resources(During the 52-week treatment period)
- Use of rescue medication(During the 52-week treatment period)
- Number of days of awakenings due to asthma and number of awakenings due to asthma(During the 52-week treatment period)
- Change from baseline in standardized asthma quality of life questionnaire score ASTHMA QUALITY OF LIFE QUESTIONNAIRES(AQLQ(S))(During the 52-week treatment period)
研究者
研究点 (1)
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