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

Keymed Biosciences

Status and phase: Begins enrollment this month; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Biological: CM512

Study type: Interventional

Funder types: Industry

Identifiers

NCT06980142

CM512-104101

Details and patient eligibility

About

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)

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 3 patient groups, including a placebo group

Dose 1

Experimental group

Treatment:

Biological: CM512

Dose 2

Experimental group

Treatment:

Biological: CM512

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo