A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

NCT ID: NCT06980142

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2028-03-17

Brief Summary

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of CM512 in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) receiving triple or double inhaled maintenance therapy, and having had 1 or more documented COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive CM512, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dose 1

Group Type: EXPERIMENTAL

CM512

Intervention Type: BIOLOGICAL

Administered SC

Dose 2

Group Type: EXPERIMENTAL

CM512

Intervention Type: BIOLOGICAL

Administered SC

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

Interventions

CM512

Administered SC

Intervention Type: BIOLOGICAL

Placebo

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 40 to ≤ 80 years old

• BMI ≥ 18.0 kg/(m*m)
• COPD diagnosis≥1 year
• Post-BD FEV1 ≥ 30% and < 80%, FEV1/FVC <0.70 at screening
• Triple (LABA+LAMA+ICS) or dual inhaled (LABA+LAMA or LABA+ICS) COPD therapy ≥3 months prior to V1
• 2 moderate or ≥1 severe COPD exacerbations in the prior year

• CAT ≥10 at screening
• Former or current smokers ≥10 pack-years

Exclusion Criteria

• Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
• Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
• Treatment with oxygen of more than 15 hours per day.
• Pregnant or breastfeeding.
• The chest/lungs with pathology that precludes the patient's ability to complete the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinfu Xu

Role: PRINCIPAL_INVESTIGATOR

Huadong Hospital

Central Contacts

Qian Jia

Role: CONTACT

qianjia@keymedbio.com

028-88610620

Other Identifiers

CM512-104101

Identifier Type: -

Identifier Source: org_study_id