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Clinical Trials in Australia / NCT06496620
Active, not recruiting Phase 2

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

NCT06496620 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2024-08-14
Last updated
2026-08-11

Condition(s) studied

COPD

Investigational drug(s) / intervention(s)

Biological: Solrikitug low dose →Biological: Solrikitug high dose →Placebo

Biological: Solrikitug low dose: Solrikitug subcutaneous injection

Biological: Solrikitug high dose: Solrikitug subcutaneous injection

Placebo: Placebo subcutaneous injection

Study summary

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (110)

FacilityCityRegionStatus
University of Alabama at Birmingham Hospital Birmingham Alabama
Syed Research Consultants Sheffield Alabama
Phoenix Medical Group Peoria Arizona
Epic Medical Research-Surprise Sun City Arizona
Alliance for Multispecialty Research Tempe Arizona
Novak Clinical Research Tucson Arizona
Antelope Valley Clinical Trials Lancaster California
Ark Clinical Research - Ballinger Long Beach California
Downtown LA Research Center, Inc. Los Angeles California
Newport Native MD, Inc. Newport Beach California
OM Research Oxnard California
Prospective Research Innovations, Inc. Rancho Cucamonga California
Velocity Clinical Research - Denver Englewood Colorado
Access Research Institute Brooksville Florida
Innovative Research of West Florida, Inc. Clearwater Florida
Clinical Research of West Florida - Clearwater Clearwater Florida
JY Research Institute Cutler Bay Florida
Hillcrest Medical Research, LLC DeLand Florida
Direct Helper Research Center Hialeah Florida
Homestead Associates in Research Inc. Homestead Florida
AppleMed Research Group, LLC Miami Florida
Y&L Advanced Health Care, Inc. Miami Florida
Reliant Medical Research LLC Miami Florida
Valencia Medical & Research Center Miami Florida
De La Cruz Research Center, LLC Miami Florida
Coral Research Clinic Corporation Miami Florida
Pro-Care Research Center, Corp. Miami Gardens Florida
San Marcus Research Clinic, Inc. Miami Lakes Florida
Florida Institute for Clinical Research Orlando Florida
Sarasota Clinical Research Sarasota Florida
TBC Research Tamarac Florida
Clinical Research of West Florida - Tampa Tampa Florida
Appalachian Clinical Research, LLC Adairsville Georgia
Pulmonology, Sleep, Asthma, and Allergy Center - Dublin Dublin Georgia
CPCC - Research, LLC East Point Georgia
Centricity Research Rincon Georgia
Velocity Clinical Research - Boise Meridian Idaho
OSF HealthCare Saint Francis Medical Center Peoria Illinois
Indiana Medical Research Institute Merrillville Indiana
The Research Group of Lexington, LLC Lexington Kentucky

+ 70 more sites — see the full list on the official registry below.

More Uniquity One (UNI) trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06496620 on ClinicalTrials.gov ↗ ← All trials in Australia