Actively Recruiting
A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
Led by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Updated on 2026-04-28
230
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form.
- Age 18 to 80 years old, male or female, weighing at least 40 kg.
- Diagnosed with asthma for at least 1 year.
- Pre-bronchodilator FEV1 at least 80% of the normal predicted value.
- Positive bronchodilation test within 24 months before informed consent or at screening.
- Receiving medium-to-high dose inhaled corticosteroids combined with at least one control drug for at least 3 months, with stable treatment for 1 month before consent.
- Asthma Control Questionnaire-5 (ACQ-6) score of 1.5 or higher.
- Experienced at least one severe asthma exacerbation within 12 months before consent and none within 30 days before consent.
- At least 80% compliance with usual asthma controller therapy during screening.
- Willing to use effective contraception from consent until 3 months after last dose.
You will not qualify if you...
- Chronic obstructive pulmonary disease (COPD) without asthma or other lung diseases impairing lung function.
- Systemic diseases or infections causing elevated eosinophils not treated or unresponsive.
- Prior autoimmune disease or biologic/immunosuppressive treatment within 8 weeks or 5 half-lives before consent.
- History of immunosuppression or frequent/recurrent infections.
- History of cancer.
- Severe or uncontrolled medical conditions such as neurological disease, severe mental disorder, or poorly controlled diabetes.
- Active or recent infections requiring treatment within 4 weeks before randomization.
- Severe cardiovascular disease or ECG abnormalities during screening.
- Major surgery requiring anesthesia or hospitalization within 8 weeks before consent.
- Use of biological agents for similar purposes within 4 months or 5 half-lives before consent.
- Participation in other clinical trials within 3 months before consent or during follow-up.
- Received immune globulin or blood products within 30 days before consent.
- Use of systemic corticosteroids for non-asthma reasons within 8 weeks before randomization.
- Received live or attenuated vaccines within 3 months before consent.
- Started desensitization therapy within 3 months before consent.
- Underwent bronchial thermoplasty within 12 months before consent.
- Current smokers or recent quitters with significant smoking history.
- Positive tests for certain infections or abnormal liver/kidney function.
- Allergy or intolerance to CM326 or placebo components.
- Heavy alcohol use within 3 months before screening.
- History of drug abuse within 5 years before consent.
- Pregnancy, lactation, or positive pregnancy test.
- Any condition preventing completion of the study as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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