Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Inflammatory response, pharmacokinetics, pharmacodynamics
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
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.
Interventions
DRUGPRA-216
biologic
DRUGPlacebo
matching placebo for PRA-216
Sponsors
Prana Therapies Inc
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
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | 40 weeks | Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe COPD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants | 40 weeks | FeNO is a non-invasive biomarker of airway inflammation in COPD. A higher number indicates higher inflammation. A reduction in FeNO levels will indicate functional activity of PRA-216. |
| Pharmacokinetics of PRA-216: T1/2 in patients with COPD | 40 weeks | Terminal elimination half-life of PRA-216 in plasma |
| Pharmacokinetics of PRA-216: AUC in patients with COPD | 40 weeks | Area under the curve of PRA-216 in plasma |
| Pharmacokinetics of PRA-216: Cmax in patients with COPD | 40 weeks | Maximum concentration of PRA-216 in plasma. |
| Immunogenicity of PRA-216: ADA in patients with COPD | 40 weeks | Incidence of anti-drug antibody following PRA-216 administration |
Outcome results
None listed