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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: COPD

In brief

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).

Key facts

Study ID

NCT06496620

Run by

Uniquity One (UNI)

People needed

171

Starts

2024-08-14

Expected to finish

2026-10-31

Last updated by the study team

2026-03-23

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Valencia Medical & Research Center — Miami, Florida, United States (enrolling)
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States (enrolling)
• Epic Medical Research-Surprise — Sun City, Arizona, United States (enrolling)
• Syed Research Consultants — Sheffield, Alabama, United States (enrolling)
• Novak Clinical Research — Tucson, Arizona, United States (enrolling)
• Phoenix Medical Group — Peoria, Arizona, United States (enrolling)
• Ark Clinical Research - Ballinger — Long Beach, California, United States (enrolling)
• Downtown LA Research Center, Inc. — Los Angeles, California, United States (enrolling)
• Alliance for Multispecialty Research — Tempe, Arizona, United States (enrolling)
• OM Research — Oxnard, California, United States (enrolling)
• Prospective Research Innovations, Inc. — Rancho Cucamonga, California, United States (enrolling)
• Velocity Clinical Research - Denver — Englewood, Colorado, United States (enrolling)
• Antelope Valley Clinical Trials — Lancaster, California, United States (enrolling)
• Access Research Institute — Brooksville, Florida, United States (enrolling)
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States (enrolling)
• Clinical Research of West Florida - Clearwater — Clearwater, Florida, United States (enrolling)
• JY Research Institute — Cutler Bay, Florida, United States (enrolling)
• Hillcrest Medical Research, LLC — DeLand, Florida, United States (enrolling)
• Newport Native MD, Inc. — Newport Beach, California, United States (enrolling)
• Direct Helper Research Center — Hialeah, Florida, United States (enrolling)
• Homestead Associates in Research Inc. — Homestead, Florida, United States (enrolling)
• AppleMed Research Group, LLC — Miami, Florida, United States (enrolling)
• Y&L Advanced Health Care, Inc. — Miami, Florida, United States (enrolling)
• Reliant Medical Research LLC — Miami, Florida, United States (enrolling)
• De La Cruz Research Center, LLC — Miami, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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