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

Launched by UNIQUITY ONE (UNI) · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called the ZION study, is looking at a new treatment called Solrikitug for people with Chronic Obstructive Pulmonary Disease (COPD). The goal is to find out if Solrikitug is safe, how well it works, and how it affects the body when given in different doses. The trial is currently recruiting participants aged 40 to 70 who have been diagnosed with COPD for at least a year and are experiencing symptoms. To qualify, participants need to be using two or more inhaled medications for their COPD and have certain lung function test results.

If you join this study, you will receive either the study drug or a placebo (a dummy treatment) without knowing which one you have. Throughout the trial, you will have regular check-ups to monitor your health and response to the treatment. It’s important to note that certain health conditions, like being pregnant or having other serious diseases, may prevent you from participating. This trial is a chance to contribute to research that could help improve COPD treatments for everyone.

Gender

ALL

Eligibility criteria

• 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.