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

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06980142

Enrollment

204

Registered

2025-05-20

Start date

2025-06-20

Completion date

2028-03-17

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

BIOLOGICALCM512

Administered SC

DRUGPlacebo

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

Primary ContactQian Jia

qianjia@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026