A Randomized, Double-blind, Placebo-controlled, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).
This is a 12-week randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 2 dose levels of solrikitug versus placebo on top of standard of care in participants with COPD. Approximately 171 eligible participants with COPD will be randomized at approximately 60-90 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. The study also includes a post-treatment follow-up period of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Solrikitug subcutaneous injection
Solrikitug subcutaneous injection
Placebo subcutaneous injection
Change from baseline in blood eosinophil counts
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Time frame: Through week 12
Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of multiple doses of solrikitug
Time frame: Through week 12 To week 28
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