NCT06496620 · Uniquity One (UNI)
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
(ZION)
What this study is about
A randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, Multiple Dose-Ranging Study to Assess the Safety, Tolerability, how the drug moves through the body, and how the drug affects the body of Solrikitug in Participants with Chronic Obstructive Pulmonary Disease (COPD).
View original scientific description
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).
Interventions
BIOLOGICAL
Biological: Solrikitug low dose
Solrikitug subcutaneous injection
BIOLOGICAL
Biological: Solrikitug high dose
Solrikitug subcutaneous injection
OTHER
Placebo
Placebo subcutaneous injection
Primary outcome measures
Change from baseline in blood eosinophil counts
Time frame: Through week 12
To assess the effect of multiple doses of solrikitug on blood eosinophil counts compared with placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 clinic
Where
- Birmingham, Alabama
- Sheffield, Alabama
- Peoria, Arizona
- Sun City, Arizona
- Tempe, Arizona
- Tucson, Arizona
- Lancaster, California
- Long Beach, California
- Los Angeles, California
- Newport Beach, California
- Oxnard, California
- Rancho Cucamonga, California
And 80 more locations — see the full list below.
Collaborators
DevPro Biopharma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations