A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT06547333 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CM310-003
• Study Type: interventional
• Target: 884
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multi-center, randomized, double-blind, placebo-controlled Phase Ⅱ/Ⅲ clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe Chronic Obstructive Pulmonary Disease（COPD）. The study has two parts. Each part consists of three periods, including an up to 4-week screening period, a 52-week randomized treatment period, and a 8-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

  Moderate acute exacerbation of COPD (AECOPD) are defined as exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. Severe AECOPD are defined as exacerbations requiring hospitalization or observation \>24 hours in emergency department/urgent care facility. For both moderate and severe events to be counted as separate events, they are separated by at least 14 days. Annualized event rate are the total number of exacerbations that occure during the treatment period divided by the total number of participant-years treated.

  Baseline (Day 1) to 52 weeks

Secondary Outcomes (20)

• Time to First Moderate or Severe Acute Exacerbation of COPD (AECOPD)

  Baseline (Day 1) to 52 weeks

• Annualized Rate of Severe Acute Exacerbations of COPD

  Baseline (Day 1) to 52 weeks

• Change from baseline in pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at week 12

  Baseline (Day 1) to 12 weeks

• Change from baseline in pre-bronchodilator FEV1 at week 52

  Baseline (Day 1) to 52 weeks

• Change from baseline in pre-bronchodilator FEV1 at week 2,4,8,16,20,24,28,36,44,48

  Baseline (Day 1) to week 2,4,8,16,20,24,28,36,44,48

Study Arms (3)

CM310 300mg Q2W

EXPERIMENTAL

CM310 is injected subcutaneously (SC) 300 mg each time, once every 2 weeks (Q2W) for a total of 26 doses.

Drug: CM310

CM310 150mg Q2W

EXPERIMENTAL

CM310 is injected subcutaneously (SC) 150 mg each time, once every 2 weeks (Q2W) for a total of 26 doses.

Drug: CM310

Placebo

PLACEBO COMPARATOR

Subcutaneous injection (SC), once every 2 weeks (Q2W) for a total of 26 doses.

Drug: Placebo

Interventions

CM310 DRUG

CM310 Recombinant Humanized Monoclonal Antibody Injection

CM310 150mg Q2W; CM310 300mg Q2W

Placebo DRUG

Placebo

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:

• Have the ability to understand the nature of 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.
• The patient has been diagnosed with COPD for at least 1 year, and meet the following criteria at screening.
• Moderate to severe COPD (post-bronchodilator FEV1/FVC ratio \<0.70 and post-bronchodilator FEV1 % predicted \>30% and ≤70%) at screening.
• Modified Medical Research Council (mMRC) Dyspnea Scale grade ≥2.
• Signs and symptoms (chronic productive cough) of chronic bronchitis for at least 3 months in the year up to screening and in the absence of other known causes of chronic cough.
• Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe AECOPD within the year prior to screening. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate acute exacerbation of COPD (AECOPD) aredefined as exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe AECOPD are defined as exacerbations requiring hospitalization or observation \>24 hours in emergency department/urgent care facility.
• Background triple therapy (ICS + LABA + LAMA) for 3 months prior to screening with a stable dose of medication for ≥1 month prior to screening; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
• Evidence of Type 2 inflammation: Patients with blood eosinophils ≥0.3×10\^9 /L at Visit 1.
• Body mass index (BMI) ≥16 kg/m\^2
• Participants (including partners) have no plans to have children and voluntarily used highly effective contraception within 3 months after the last dose of study drug from the date of signing the informed consent.

You may not qualify if:

• A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted 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.
• Subjects with other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, eosinophilic granulomatosis with polyangiitis (EGPA), eosinophilic esophagitis or other disease(e.g., active parasitic infection (helminthes) which has not been treated with, or has failed to respond to standard of care therapy.)
• Heart failure NYHA Class IV, uncontrolled Cor pulmonale as judged by the Investigator or with evidence of right cardiac failure.
• Treatment with oxygen of more than 15 hours per day or hypercapnia requiring BiPAP, in the opinion of the investigator,
• Acute infection requiring systemic anti-infective therapy from 4 weeks before signing consent to the time of randomization.
• History of or planned pneumonectomy or lung volume reduction surgery for COPD. 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).
• Diagnosis of α-1 anti-trypsin deficiency.
• Anti-immunoglobulin E (IgE) therapy (omalizumab) within 130 days before consent or any other biologic therapy (including other anti-IL4R mAb, anti-IL5 mAb, anti-IL5R mAb, anti TSLP mAb, anti-IL33 mAb, anti-ST2 mAb) within 3 months or 5 half-lives before signing consent, whichever is longer.
• Prior autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc) or inflammatory treatment with biologic agents/systemic immunosuppressive agents (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) within 8 weeks or 5 half-life periods (whichever is longer) prior to consent.
• Receipt of immune globulin or blood products within 30 days before consent.
• Patients who are treated with systemic corticosteroids (topical, ophthalmic, or intranasal corticosteroids are excluded) from 4 weeks before signing the informed consent to the date of randomization. Except for short-term (≤7 days) use of systemic glucocorticoids to prevent or treat non-autoimmune allergic diseases.
• Use of macrolide antibiotics (eg, azithromycin) unless stable \>3 months prior to screening visit and maintain the treatment during the planned study period.
• Receipt of live or attenuated vaccine within 3 months before consent signing or during the planned study period
• Previous history of known or suspected immunosuppression, including a history of invasive opportunistic infection (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), even if the infection has resolved; Or the presence of unusual frequent, recurrent, or prolonged infections, per investigator's judgment.

Sponsors & Collaborators

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

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

86-0311-69085587; 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: August 7, 2024
• First Posted: August 9, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): April 29, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: August 14, 2024

Record last verified: 2024-08