A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CM512, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Overview
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
- Biological CM512
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Annualised rate of moderate or severe COPD exacerbations [Time frame: Baseline up to 52 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06980142 · CM512-104101