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New treatment option for COPD
Official title A Study to Evaluate Solrikitug in Participants With COPD (ZION)
ClinicalTrials.gov ID: NCT06496620
What this study is testing
What is Biological: Solrikitug low dose?
Biological: Solrikitug low dose is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for copd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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...
- 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...
- 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.
You likely can't join if
- 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...
- Participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Sheffield, Alabama, United States
- Peoria, Arizona, United States
- Sun City, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Oxnard, California, United States
- Rancho Cucamonga, California, United States
- Englewood, Colorado, United States
- New Haven, Connecticut, United States
- Brooksville, Florida, United States
- Clearwater, Florida, United States
- Cutler Bay, Florida, United States
- DeLand, Florida, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
+ 87 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Sheffield, Alabama, United States; Peoria, Arizona, United States; Sun City, Arizona, United States; Tempe, Arizona, United States; Tucson, Arizona, United States and 101 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.