COPD
Conditions
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.
Interventions
BIOLOGICALBiological: Solrikitug low dose
Solrikitug subcutaneous injection
BIOLOGICALBiological: Solrikitug high dose
Solrikitug subcutaneous injection
OTHERPlacebo
Placebo subcutaneous injection
Sponsors
Uniquity One (UNI)
DevPro Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, New Zealand, United Kingdom, United States
Contacts
STUDY_DIRECTORAndrew W Lee, MD
Vice President, Clinical Research
Outcome results
None listed