Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of CM326 in Adults 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
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CM326, a recombinant humanized monoclonal antibody, in people with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This Phase II, multi-center, randomized, double-blind, placebo-controlled study aims to assess the medicine's effectiveness, safety, how the body processes it, its biological effects, and immune response in adults aged 40 to 85 years with a COPD diagnosis lasting at least one year. The study is sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Participants will be randomly assigned to receive one of two doses of CM326 or a placebo, each given by subcutaneous injection. The study includes a screening period of up to four weeks, followed by a 24 to 52-week treatment phase, and then a 12-week safety follow-up period. During the trial, participants will continue their stable background COPD therapy and are required to use highly effective contraception if applicable. Throughout the study, participants will undergo assessments including lung function tests like forced expiratory volume (FEV1), forced vital capacity (FVC), and forced expiratory flow (FEF), as well as questionnaires measuring respiratory symptoms and quality of life. Researchers will monitor the rate and timing of COPD exacerbations, changes in blood markers, immune responses, and any adverse events. The total participation time may last up to approximately 68 weeks, including all study phases.
CONDITIONS
Brief 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 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 between 20% and 80% predicted.
- Stable background COPD therapy for at least 1 month prior to screening.
- History of at least 2 moderate or 1 severe COPD exacerbations in the past year.
- COPD Assessment Test (CAT) total score of 10 or more.
- Blood eosinophils of at least 0.15 x 10^9/L at screening.
- Current or former smoker with at least 10 pack-years or exposure to biomass smoke for 10 years or more.
- Willingness to use highly effective contraception from consent until 3 months after last dose.
You will not qualify if you...
- Current or past diagnosis of asthma as primary diagnosis or asthma with COPD.
- Significant lung diseases other than COPD or conditions causing elevated eosinophils.
- Severe or uncontrolled medical conditions affecting drug evaluation, including neurological, mental, cardiovascular diseases, or uncontrolled diabetes.
- History of cancer.
- Known or suspected immunosuppression or frequent infections.
- Recent use of biologic or systemic immunosuppressive treatments.
- Severe heart failure or recent heart attack, unstable angina, or stroke.
- Recent parasitic infection not treated.
- COPD exacerbation or infection requiring systemic antibiotics within 4 weeks before randomization.
- Recent major surgery or planned surgery requiring hospitalization.
- History or planned lung surgery for COPD within 12 months.
- Long-term oxygen therapy over 15 hours per day or need for BiPAP ventilation.
- Participation in acute phase pulmonary rehabilitation within 4 weeks before screening.
- Recent systemic corticosteroid use except short-term for non-autoimmune allergies.
- Use of certain antibiotics or PDE-4 inhibitors unless stable for 3 months.
- Recent use of anti-IgE or other biologic therapies.
- Participation in other drug or device trials within 3 months.
- Recent immune globulin or blood product use.
- Recent use of traditional Chinese medicines for COPD.
- Recent live or attenuated vaccination.
- Positive HIV test or untreated syphilis.
- Chronic hepatitis B or C infection with active viral replication.
- Elevated liver enzymes or kidney function tests.
- Pregnant or breastfeeding females.
- Allergy to CM326 or placebo components or severe drug allergies.
- History of drug abuse within 5 years.
- Poor compliance with COPD controller therapy during screening.
- Any condition preventing study completion as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Week 0 to Week 52
Participants receive subcutaneous injections of CM326 at two dose levels or placebo as part of the study treatment.
Regular visits during 52 weeks for treatment administration and assessments
Duration - Up to Week 64
Participants are monitored for safety and treatment effects after the treatment period ends.
Visits for safety and pharmacokinetic assessments up to 12 weeks after treatment ends
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
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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