This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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
Time frame: 40 weeks
The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants
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.
Time frame: 40 weeks
Pharmacokinetics of PRA-216: T1/2 in patients with COPD
Terminal elimination half-life of PRA-216 in plasma
Time frame: 40 weeks
Pharmacokinetics of PRA-216: AUC in patients with COPD
Area under the curve of PRA-216 in plasma
Time frame: 40 weeks
Pharmacokinetics of PRA-216: Cmax in patients with COPD
Maximum concentration of PRA-216 in plasma.
Time frame: 40 weeks
Immunogenicity of PRA-216: ADA in patients with COPD
Incidence of anti-drug antibody following PRA-216 administration
Time frame: 40 weeks
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