A Study to Evaluate Solrikitug in Participants With COPD (ZION)

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.

Inclusion Criteria: * At least 40 years of age and no older than 75 years. * Documented diagnosis of COPD for at least 12 months prior to Screening, defined by the GOLD Guidelines (2023), and elevated blood eosinophils at screening. * At Screening FEV1/FVC ratio must be \<0.70, and Post-bronchodilator FEV1 must be ≥40% to \<80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017). * Symptomatic (COPD Assessment Test \[CAT\] Score ≥10) at Screening Visit 1. * Participants must be on 2 or more inhaled maintenance medications for management of their COPD, for at least 3 months prior to screening. Exclusion Criteria: * Female participant who is pregnant or breastfeeding. * Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody. * Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the Investigator or Medical Monitor might obfuscate the study data. * Any other pulmonary disease than COPD that in the opinion of the Investigator, the severity of the disorder would impact the conduct of the study. * Undergone major lung surgery, within 1 year of Screening Visit 1. * Participant has a lower respiratory tract infection that required antibiotics within 6 weeks prior to Screening.