NCT07372287
Recruiting
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Study of Evaluating the Efficacy and Safety of CM326 in Subjects With Moderate to Severe Asthma
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 site in 1 country230 target enrollmentStarted: January 23, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Annualized rate of severe asthma exacerbations at Week 52
Overview
Brief Summary
This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to severe asthma.
The study consists of three periods, including an up to 4-week screening period, a 52-week double-blind randomized treatment period, and a 12-week safety follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Understand the study and voluntarily sign the informed consent form.
- •Age ≥18 and ≤80 years old, male or female, weight ≥40 kg.
- •The subject has been diagnosed with asthma for at least 1 year.
- •Pre-bronchodilator FEV1 measured ≤80% of the normal predicted value.
- •A positive bronchodilation test within 24 months before informed 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, Oral corticosteroids, 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-6) score ≥1.
- •Subjects must have experienced at least one severe asthma exacerbation event within 12 months before informed consent, and have not experienced a severe asthma exacerbation event within 30 days before informed consent.
- •≥ 80% compliance with usual asthma controller therapy in subjects during the screening phase
- •Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.
Exclusion Criteria
- •Chronic obstructive pulmonary disease (COPD) without asthma or other lung disease that may impair lung function, as judged by the investigator.
- •Have systemic diseases other than asthma that result in an elevated peripheral blood eosinophil count or other diseases such as helminth parasitic infections for which standard treatment is not received or does not respond.
- •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.
- •Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection, even if the infection has resolved; or the presence of unusual frequent, recurrent, or prolonged infections.
- •History of malignancy.
- •The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator may affect the evaluation of the drug, including but not limited to: severe neurological disease, history of severe mental disorder, diabetes mellitus poorly controlled by intensive treatment.
- •Active infection or acute infection requiring systemic anti-infective therapy from 4 weeks before enrollment to the time of randomization.
- •A history of severe cardiovascular disease or clinically significant abnormalities identified by 12-lead electrocardiogram (ECG) during the screening phase.
- •Major surgery within 8 weeks prior to informed consent requiring general anesthesia or hospitalization for \> 1 day .
- •Received biological agents with the same therapeutic purpose within 4 months or 5 half-lives (whichever is longer) before signing the informed consent.
Arms & Interventions
Placebo
Placebo Comparator
placebo, subcutaneous (SC)
Intervention: Placebo (Other)
CM326
Experimental
CM326 subcutaneous (SC)
Intervention: CM326 (Drug)
Outcomes
Primary Outcomes
Annualized rate of severe asthma exacerbations at Week 52
Time Frame: week 52
Severe asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, or an inpatient hospitalization due to asthma. The annualized rate of severe asthma exacerbations is presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.
Secondary Outcomes
- Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52(week 52)
- Annualized rate of subjects experiencing the event of loss of asthma control (LOAC) at Week 52(week 52)
- Annualized rate of severe asthma exacerbations associated with emergency room visit, or hospitalization at Week 52(week 52)
- Time to the first onset of the severe asthma exacerbation event(week 52)
- Time to the onset of the first event of LOAC(week52)
- Change from baseline in Pre-bronchodilator FEV1 percentage of predicted value (FEV1% Pred) at each evaluation time point(week 52)
- Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point(week 52)
- Change from baseline in Pre-bronchodilator Maximal Mid-Expiratory FlowForced Expiratory Flow (MMEF) at each evaluation time point(week 52)
- Change from baseline in post-bronchodilator FEV1 at each evaluation time point(week 52)
- Proportion of participants with an ACQ-6 Score improvement of ≥0.5 points from baseline at each evaluation time point(week 52)
- Change from baseline in weekly mean morning and evening peak expiratory flow (PEF) at each evaluation time(week 52)
- Change from baseline in the Asthma Control Questionnaire-6(ACQ-6) score at each evaluation time point(week 52)
- Change from baseline in the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)+12) score at each evaluation time point(week 52)
- Proportion of participants with an (AQLQ(S)+12) Score improvement of ≥0.5 points from baseline at each evaluation time point(week 52)
- Change from baseline in asthma symptom score at each evaluation time point(week 52)
- Change from baseline in weekly mean rescue medication use at each evaluation(week 52)
- Change from baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) score at each evaluation time point(week 52)
- Change from baseline in peripheral blood eosinophil(week 64)
- Incidence and severity of Adverse events (AEs)(week 64)
- Blood drug concentration of CM326(week 64)
- Change from baseline fractional exhaled nitric oxide (FeNO)(week 64)
- Change from baseline in total serum IgE(week 64)
- Change from baseline in interleukin-5(week 64)
- Incidence of anti-drug antibodies (ADAs)(week 64)
Investigators
Study Sites (1)
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