Status:
RECRUITING
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
Lead Sponsor:
Uniquity One (UNI)
Collaborating Sponsors:
DevPro Biopharma
Conditions:
COPD
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief 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 Obstru...
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 place...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT06496620
Start Date
August 14 2024
End Date
October 31 2026
Last Update
November 24 2025
Active Locations (88)
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1
Research Site 034
Birmingham, Alabama, United States, 35294
2
Research Site 099
Peoria, Arizona, United States, 85381
3
Research Site 051
Sun City, Arizona, United States, 85351
4
Research Site 033
Tempe, Arizona, United States, 85281