A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT07418736 | Recruiting Phase 2

• 1 other identifier: CM326-003
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbations

  Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.

  week 24-52

Secondary Outcomes (21)

• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point

  week 16-24

• Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point

  week 24-52

• Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at each evaluation time point

  week 24-52

• Change from baseline in Pre-bronchodilator Forced vital capacity (FVC) at each evaluation time point

  week 24-52

• Change from baseline in forced expiratory flow (FEF) at 25%-75% at each evaluation time point

  week 24-52

Study Arms (2)

CM326

EXPERIMENTAL

CM326 is dosed at two levels.

Drug: CM326 dose 1; Drug: CM326 dose 2

Placebo

PLACEBO COMPARATOR

placebo, subcutaneous (SC)

Other: Placebo

Interventions

CM326 dose 1 DRUG

subcutaneous injection

CM326

CM326 dose 2 DRUG

subcutaneous injection

CM326

Placebo OTHER

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the study and voluntarily sign the informed consent form.
• Age ≥40 and ≤85 years old, male or female, at the time of signing the informed consent.
• weight ≥40 kg.
• Diagnosed with COPD for at least 12 months.
• Post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted ≥20% and \<80%.
• Background therapy for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening.
• Exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening.
• COPD assessment test (CAT) Total Score ≥10.
• Blood eosinophils ≥0.15×10\^9 /L at screening.
• Current smoking or a history of smoking ≥ 10 pack-years, or exposure to biomass smoke (including but not limited to biomass fuel, secondhand smoke, and the like) for ≥ 10 years.
• Voluntarily use highly effective contraception from the time of signing the informed consent form until 3 months after the last dose.

You may not qualify if:

• A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines（asthma alone or asthma as the primary diagnosis, including but not limited to asthma with COPD）
• Subjects with significant pulmonary disease other than COPD (e.g., sarcoidosis, interstitial lung disease, primary pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, active tuberculosis or non-tuberculous mycobacterial infection, etc.), in the opinion of the investigator. Or other conditions that could lead to elevated eosinophils.
• The presence of any severe and/or uncontrolled medical condition that in the judgment of the investigator would affect the evaluation of the drug, including but not limited to: severe neurological disease (eg, epilepsy, dementia, etc), history of severe mental disorder, major cardiovascular disease, diabetes mellitus poorly controlled by intensive treatment, QTcF interval prolongation（male \>450 msec, female \>470 msec）, or persistent arrhythmia.
• History of malignancy.
• Previous history of known or suspected immunosuppression; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.
• 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.
• Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the investigator or with evidence of right cardiac failure.
• Myocardial infarction, unstable angina, or stroke occurring within 6 months prior to signing the informed consent form (ICF).
• Parasitic infection diagnosed within 24 weeks prior to signing the informed consent form (ICF), which has not received standard treatment or is refractory to standard treatment.
• Acute moderate or severe exacerbation of COPD from 4 weeks before signing consent to the time of randomization.
• Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization.
• Major surgery within 8 weeks prior to consent or planned surgery requiring general anesthesia or hospitalization for \> 1 day during the study period.
• History of or planned pneumonectomy or lung volume reduction surgery for COPD 12 months prior to screening.
• As judged by the investigator, long-term daily oxygen therapy for more than 15 hours per day due to medical necessity, or concurrent hypercapnia requiring the use of bilevel positive airway pressure (BiPAP) non-invasive ventilation.
• Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who start rehabilitation \<4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program could be included).

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 10, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)