A Study to Evaluate Solrikitug in Participants With COPD (ZION)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological: Solrikitug low dose, Biological: Solrikitug high dose, Placebo.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, New Zealand, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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 (ZION)
Overview
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.
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]
Secondary outcome measures (1)
- Change from baseline in FEV1 Adverse events (AEs) and serious adverse events (SAEs) [Time frame: Through week 12 To week 28]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 101 centers
- University of Alabama at Birmingham Hospital — Birmingham
- Syed Research Consultants — Sheffield
- Phoenix Medical Group — Peoria
- Epic Medical Research-Surprise — Sun City
- Alliance for Multispecialty Research — Tempe
- Novak Clinical Research — Tucson
- Antelope Valley Clinical Trials — Lancaster
- Ark Clinical Research - Ballinger — Long Beach
- … and 93 more centers
New Zealand · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Australia · 4 centers
Center list to be confirmed — check the primary protocol.
Canada · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06496620 · NSI-8226-205