PRA-216 COPD Safety and Biomarker Study

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of PRA-216, administered by SC injection in participants with moderate to severe COPD who are on standard of care treatment consisting of dual (ICS/LAMA or ICS/LABA) or triple inhaled maintenance therapy (ICS, LABA and LAMA).

The study will enroll approximately 40 participants at multiple study site and participants will be randomized 1:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.

Inclusion criteria

• Age 40-80
• Willing and able to attend all study visits, comply with study requirements.
• Able and willing to provide written informed consent
• Documented COPD diagnosis prior for at least 12 months prior to screening.
• Currently receiving maintenance COPD medications at a stable dose for at least 2 months prior to visit 1

Exclusion criteria

• Evidence of clinically significant pulmonary condition or disease other than COPD
• Any physical or psychological condition that prohibits study completion
• Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism within 12 months prior to the first dose of study agent
• History of severe allergic reactions or hypersensitivity
• Receipt of immunosuppressant therapies for asthma within 3 months of screening
• Major surgery occurring within 8 weeks months prior to first dose of investigational product.
• Use of any marketed or investigational monoclonal or polyclonal antibody therapy within 4 months or 5 half-lives prior to visit 1.