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 (ZION)
Uniquity One (UNI)
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).
Description
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.
Eligibility
- Age range
- 40–75 years
- Sex
- All
- 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 m…
Interventions
- BiologicalBiological: Solrikitug low dose
Solrikitug subcutaneous injection
- BiologicalBiological: Solrikitug high dose
Solrikitug subcutaneous injection
- OtherPlacebo
Placebo subcutaneous injection
Locations (118)
- University of Alabama at Birmingham HospitalBirmingham, Alabama
- Syed Research ConsultantsSheffield, Alabama
- Phoenix Medical GroupPeoria, Arizona
- Epic Medical Research-SurpriseSun City, Arizona
- Alliance for Multispecialty ResearchTempe, Arizona
- Novak Clinical ResearchTucson, Arizona