A Study to Evaluate Solrikitug in Participants With COPD (ZION)
- Conditions
- COPD
- Interventions
- Other: Placebo
- Registration Number
- NCT06496620
- Lead Sponsor
- Uniquity One (UNI)
- 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 Obstructive Pulmonary Disease (COPD).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 171
- 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 โฅ40% to <80% predicted normal value calculated using Global Lung Function Initiative (GLI) reference equations (Cooper et al 2017).
- Symptomatic (COPD Assessment Test [CAT] Score โฅ10) 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change from baseline in blood eosinophil counts Through week 12 To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
- Secondary Outcome Measures
Name Time Method Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs) Through week 12 To week 28 To assess the safety and tolerability of multiple doses of solrikitug
Trial Locations
- Locations (48)
Research Site 051
๐บ๐ธSurprise, Arizona, United States
Research Site 033
๐บ๐ธTempe, Arizona, United States
Research Site 032
๐บ๐ธLos Angeles, California, United States
Research Site 041
๐บ๐ธOxnard, California, United States
Research Site 049
๐บ๐ธClearwater, Florida, United States
Research Site 052
๐บ๐ธMiami, Florida, United States
Research Site 042
๐บ๐ธLexington, Kentucky, United States
Research Site 037
๐บ๐ธFarmington Hills, Michigan, United States
Research Site 062
๐บ๐ธMissoula, Montana, United States
Research Site 044
๐บ๐ธCortland, New York, United States
Research Site 043
๐บ๐ธHorseheads, New York, United States
Research Site 050
๐บ๐ธCharlotte, North Carolina, United States
Research Site 039
๐บ๐ธHuntersville, North Carolina, United States
Research Site 036
๐บ๐ธColumbus, Ohio, United States
Research Site 047
๐บ๐ธGrants Pass, Oregon, United States
Research Site 053
๐บ๐ธPittsburgh, Pennsylvania, United States
Research Site 040
๐บ๐ธHendersonville, Tennessee, United States
Research Site 048
๐บ๐ธKnoxville, Tennessee, United States
Research Site 031
๐บ๐ธLancaster, California, United States
Research Site 018
๐บ๐ธNewport Beach, California, United States
Research Site 020
๐บ๐ธEnglewood, Colorado, United States
Research Site 002
๐บ๐ธClearwater, Florida, United States
Research Site 035
๐บ๐ธCutler Bay, Florida, United States
Research Site 004
๐บ๐ธMiami, Florida, United States
Research Site 013
๐บ๐ธOrlando, Florida, United States
Research Site 007
๐บ๐ธSarasota, Florida, United States
Research Site 001
๐บ๐ธTampa, Florida, United States
Research Site 003
๐บ๐ธRincon, Georgia, United States
Research Site 021
๐บ๐ธMeridian, Idaho, United States
Research Site 022
๐บ๐ธMerrillville, Indiana, United States
Research Site 017
๐บ๐ธDartmouth, Massachusetts, United States
Research Site 009
๐บ๐ธSaint Charles, Missouri, United States
Research Site 015
๐บ๐ธHenderson, Nevada, United States
Research Site 005
๐บ๐ธGastonia, North Carolina, United States
Research Site 008
๐บ๐ธHigh Point, North Carolina, United States
Research Site 006
๐บ๐ธWilmington, North Carolina, United States
Research Site 014
๐บ๐ธWinston-Salem, North Carolina, United States
Research Site 011
๐บ๐ธMedford, Oregon, United States
Research Site 023
๐บ๐ธAnderson, South Carolina, United States
Research Site 028
๐บ๐ธColumbia, South Carolina, United States
Research Site 027
๐บ๐ธGreenville, South Carolina, United States
Research Site 010
๐บ๐ธRock Hill, South Carolina, United States
Research Site 024
๐บ๐ธSpartanburg, South Carolina, United States
Research Site 029
๐บ๐ธUnion, South Carolina, United States
Research Site 016
๐บ๐ธBoerne, Texas, United States
Research Site 025
๐บ๐ธHouston, Texas, United States
Research Site 012
๐บ๐ธMcKinney, Texas, United States
Research Site 019
๐บ๐ธHampton, Virginia, United States