Actively Recruiting
A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2026-02-18
318
Participants Needed
1
Research Sites
94 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 II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM326 in subjects with moderate to Severe Chronic Obstructive Pulmonary Disease. The study consists of a screening period of up to 4 weeks, a randomized treatment period of 24 to 52 weeks, and a 12-week safety follow-up period.
CONDITIONS
Official Title
A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form.
- Age 40 to 85 years, male or female, at the time of signing the informed consent.
- Weight 40 kg or more.
- Diagnosed with COPD for at least 12 months.
- Post-bronchodilator FEV1/FVC ratio less than 0.70 and post-bronchodilator FEV1 % predicted 20% or more and less than 80%.
- Stable background COPD therapy for at least 1 month prior to screening and use of this therapy for 3 months prior to screening.
- History of 2 or more moderate or 1 or more severe acute exacerbations of COPD within the year prior to screening.
- COPD assessment test (CAT) total score 10 or higher.
- Blood eosinophils 0.15 x 10^9/L or higher at screening.
- Current smoking or history of smoking 10 or more pack-years, or exposure to biomass smoke for 10 or more years.
- Voluntarily use highly effective contraception from signing informed consent until 3 months after last dose.
You will not qualify if you...
- Current diagnosis or history of asthma according to GINA guidelines.
- Significant pulmonary diseases other than COPD as judged by the investigator.
- Severe or uncontrolled medical conditions that could affect drug evaluation, including severe neurological disease, severe mental disorder, major cardiovascular disease, poorly controlled diabetes, prolonged QTcF interval, or persistent arrhythmia.
- History of malignancy.
- Known or suspected immunosuppression or frequent, recurrent, or prolonged infections.
- Prior autoimmune disease or recent treatment with biologic or systemic immunosuppressive agents.
- Heart failure NYHA Class IV, uncontrolled Cor pulmonale, or evidence of right heart failure.
- Recent myocardial infarction, unstable angina, or stroke within 6 months before consent.
- Untreated or refractory parasitic infection within 24 weeks prior to consent.
- Acute moderate or severe COPD exacerbation or infection requiring systemic therapy within 4 weeks before consent.
- Recent major surgery or planned surgery requiring hospitalization during the study.
- History of or planned lung surgery for COPD within 12 months prior to screening.
- Long-term oxygen therapy more than 15 hours daily or use of BiPAP due to hypercapnia.
- Participation in acute phase of pulmonary rehabilitation program within 4 weeks prior to screening.
- Systemic corticosteroid use within 4 weeks before consent except short-term use for non-autoimmune allergic diseases.
- Use of macrolide antibiotics or PDE-4 inhibitors unless stable treatment maintained.
- Recent treatment with anti-IgE or other biologic therapies before consent.
- Enrollment in other clinical trials or follow-up within 3 months or 5 half-lives before consent.
- Recent immune globulin or blood products within 30 days before consent.
- Use of traditional Chinese medicines or natural medicines for COPD within 4 weeks prior to randomization.
- Receipt of live or attenuated vaccine within 3 months before consent or during study.
- Non-negative HIV test or untreated Treponema pallidum infection.
- Chronic hepatitis B or C infection with certain laboratory abnormalities.
- Elevated liver enzymes or serum creatinine above specified limits.
- Pregnant, lactating, or positive pregnancy test females.
- Allergy or intolerance to study drug components or history of severe drug allergy.
- History of drug abuse within 5 years before consent.
- Less than 70% compliance with usual COPD controller therapy during screening.
- Any condition that may prevent study completion as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here