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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• University of Alabama at Birmingham Hospital, Birmingham, Alabama, United States
• Syed Research Consultants, Sheffield, Alabama, United States
• Phoenix Medical Group, Peoria, Arizona, United States
• Epic Medical Research-Surprise, Sun City, Arizona, United States
• Alliance for Multispecialty Research, Tempe, Arizona, United States
• Novak Clinical Research, Tucson, Arizona, United States
• Antelope Valley Clinical Trials, Lancaster, California, United States
• Ark Clinical Research - Ballinger, Long Beach, California, United States
• Downtown LA Research Center, Inc., Los Angeles, California, United States
• Newport Native MD, Inc., Newport Beach, California, United States
• OM Research, Oxnard, California, United States
• Prospective Research Innovations, Inc., Rancho Cucamonga, California, United States

+ 106 more sites.

Who to contact

Uniquity One Clinical Trials · 484-267-2500 · ClinicalTrials@uniquity.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06496620.