A Study to Evaluate Solrikitug in Participants With COPD (ZION)
Purpose
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).
Condition
- COPD
Eligibility
- Eligible Ages
- Between 40 Years and 75 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Biological: Solrikitug High Dose |
Solrikitug |
|
|
Other Placebo |
Placebo |
|
|
Experimental Biological: Solrikitug Low Dose |
Solrikitug |
|
Recruiting Locations
Birmingham, Alabama 35294
Research Site 034
More Details
- Status
- Recruiting
- Sponsor
- Uniquity One (UNI)
Detailed 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.