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

Phase 2

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Biological: CM512; Drug: Placebo

• Registration Number: NCT06980142
• Lead Sponsor: Keymed Biosciences Co.Ltd

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-20
• Primary Completion: 2028-03-17
• Study Completion: 2028-03-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	CM512	-
Dose 2	CM512	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Annualised rate of moderate or severe COPD exacerbations	Baseline up to 52 weeks	The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 52 weeks treatment period compared to placebo.