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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-85
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CM310
  • Placebo

Treatment groups

884 Participants
are divided into 3 treatment groups

Locations

This trial has no locations