NCT06980142Not yet recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 12 May 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 17 Mar 2028
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Diseases
- COPD
- NCT number
- NCT06980142
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 204
- From 20 Jun 2025 to the primary completion date, 17 Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with oxygen of more than 15 hours per day.
Other illness
- 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.
Other
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study.
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.