The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
Eligibility
Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* Physician diagnosis of COPD for \>12 months.
* Current or former smokers with a smoking history of 10 pack-years or more.
* Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio \<0.70 and predicted post-bronchodilator FEV1 \>30% and ≤80%.
* Modified Medical Research Council dyspnea scale Grade ≥2.
* Background triple therapy (Inhaled Corticosteroid \[ICS\], Long-Acting Beta Agonist \[LABA\], Long-Acting Muscarinic Antagonist \[LAMA\]) for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit 1.
* Are ≥80% compliant with background therapy during the screening period.
Exclusion Criteria:
* Moderate or severe exacerbation of COPD within 4 weeks prior to or during the screening period.
* Respiratory tract infection within 4 weeks prior to or during the screening period.
* Treatment with oxygen of \>4 liters/minute. Nocturnal oxygen use for sleep apnea is allowed.
* Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids. Treatment with cyclophosphamide and rituximab within 12 months of Visit 1.
* Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines
* History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
* Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded.
* Any of the following in the previous 6 months prior to Visit 1: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis and cardiac arrhythmias including paroxysmal (e.g., intermittent). Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.
Primary outcome measure(s)
Annualized rate of moderate or severe COPD exacerbation events — From Day 1 (Baseline) up to Week 108
Trial sites (242)
Facility
City
Region
Status
Kern Research Inc.
Bakersfield
California
PulmoCrit Associates
Encino
California
Torrance Clinical Research Institute
Lomita
California
Dream Team Clinical Research
Pomona
California
Apex Clinical Research
San Diego
California
Allianz Research Institute
Westminster
California
D&H Doral Research Center, LLC
Doral
Florida
Qway Research, LLC
Hialeah
Florida
Finlay Medical Research
Miami
Florida
MplusM - ITB Research
Miami
Florida
Florida Institute for Clinical Research,LLC
Orlando
Florida
Velocity Clinical Research-Savannah - Internal Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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