A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点分布在 1 个国家目标入组 600 人2023年4月28日

适应症Moderate to Severe Asthma

干预措施CM310 Placebo

概览

阶段: 2 期
干预措施: CM310
疾病 / 适应症: Moderate to Severe Asthma
发起方: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
入组人数: 600
试验地点: 1
主要终点: Annualized rate of severe asthma exacerbations
状态: 招募中
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma.

The study consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 4-week safety follow-up period.

注册库

clinicaltrials.gov

开始日期

2023年4月28日

结束日期

2032年5月

最后更新

2年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•Have the ability to understand the study and voluntarily sign the informed consent form.
•Age ≥12 and ≤75 years old, male or female, weight ≥40 kg.
•The subject has been diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of GINA
•Pre-bronchodilator FEV1 measured ≤ 80% of the normal predicted value at screening and baseline visits (V1 and V2).
•A positive bronchodilation test (≥12% increase in the FEV1 post-bronchodilator and an absolute FEV1 increase of ≥200 mL) within 24 months before consent or at screening.
•The subject has received medium-to-high dose ICS combined with at least one control drug, such as LABA, LAMA, LTRA, theophylline, for at least 3 months before signing the informed consent, and maintained stable treatment regimen and dosage for at least 1 month before signing the informed consent.
•Asthma Control Questionnaire-5 (ACQ-5) score ≥1.5 at screening and baseline visits (V1 and V2).
•Subjects must have experienced at least one severe asthma exacerbation event within 12 months before consent, and have not experienced a severe asthma exacerbation event within 1 month before consent, with at least one severe asthma exacerbation event occurring during treatment with medium-to-high dose ICS.
•Subjects (including partners) have no plans to have children and voluntarily use highly effective contraception within 3 months after the last dose of study drug from the date of signing the informed consent.

排除标准

•Received biological agents with the same therapeutic purpose within 6 months before signing the informed consent.
•Prior autoimmune disease or inflammatory treatment with biologic agents/systemic immunosuppressive agents within 8 weeks or 5 half- lives (whichever is longer) prior to informed consent.
•Received immune globulin or blood products within 30 days before informed consent.
•Subjects treated with systemic corticosteroids (except for topical, ophthalmic, or intranasal corticosteroids) from 4 weeks before signing the informed consent to the date of randomization.
•Received live or attenuated vaccine within 3 months before informed consent signing or planned to receive live or attenuated vaccine during the study period.
•Initiation of desensitization therapy within 3 months before informed consent.
•Underwent bronchial thermoplasty within 12 months before informed consent.
•Current smokers or former smokers who quit smoking less than 6 months or former smokers who quit smoking more than 6 months with a smoking history of more than 10 pack-years.
•Chronic obstructive pulmonary disease (COPD) or other lung disease that may impair lung function, as judged by the investigator.
•Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.

研究组 & 干预措施

CM310 high dose

CM310 is injected subcutaneously (SC) with a loading dose at the first dose, and then high dose thereafter, once every 2 weeks (Q2W) for a total of 26 doses.

干预措施: CM310

CM310 low dose

CM310 is injected subcutaneously (SC) with a loading dose at the first dose, and then low dose thereafter, once every 2 weeks (Q2W) for a total of 26 doses.

干预措施: CM310

Placebo

Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 26 doses.

干预措施: Placebo

结局指标

主要结局

Annualized rate of severe asthma exacerbations

时间窗: 52 weeks

次要结局

Change from baseline in pre-bronchodilator Forced expiratory volume in 1 second (FEV1) at Week 12(56 weeks)
Change from baseline in FEV1 percentage of predicted value (FEV1% Pred)(56 weeks)
Change from baseline in FEV1 after the use of bronchodilator(56 weeks)
Change from baseline in Peak diurnal and nocturnal expiratory flow (PEF)(56 weeks)
Change from baseline in asthma symptom score at each evaluation time point(56 weeks)
Change from baseline in the number of inhalations of SABA(56 weeks)
Change from baseline in human thymus and activation-regulated chemokine (TARC)(56 weeks)
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)(56 weeks)
The plasma concentration of CM310(56 weeks)
Change from baseline in total IgE (immunoglobulin E)(56 weeks)
Rate of change from baseline in pre-bronchodilator FEV1 at Week 12(56 weeks)
Time to the onset of the first event of LOAC(52 weeks)
Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)) score at each evaluation time point(56 weeks)
Change from baseline in fractional exhaled nitric oxide (FeNO)(56 weeks)
Change from baseline in Forced vital capacity (FVC)(56 weeks)
Change from baseline in Forced Expiratory Flow (FEF) 25-75%(56 weeks)
Annualized rate of subjects experiencing the event of loss of asthma control (LOAC)(52 weeks)
Annualized rate of severe asthma exacerbations leading to hospitalization or emergency department observation(52 weeks)
Time to the first onset of the severe asthma exacerbation event(52 weeks)
Change from baseline in the Asthma Control Questionnaire-5 (ACQ-5) score at each evaluation time point(56 weeks)
Incidence of Adverse events (AEs)(56 weeks)