Phase
Condition
N/ATreatment
Placebo
Verekitug
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 predictedpost-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 randomizationwith 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
Exclusion Criteria:
Moderate or severe exacerbation of COPD within 4 weeks prior to or during thescreening 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 isallowed.
Systemic or biologic immunosuppressant therapy to treat inflammatory disease orautoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever islonger, with the exception of oral corticosteroids. Treatment with cyclophosphamideand rituximab within 12 months of Visit 1.
Current diagnosis of asthma according to the 2023 Global Initiative for Asthmaguidelines or other accepted guidelines
History or evidence of a clinically meaningful pulmonary condition other than COPD (e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonaryhypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonaryor systemic disease associated with elevated peripheral eosinophil counts.
Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participantsrequiring BiPAP periodically for an acute COPD exacerbation are not excluded.
Any of the following in the previous 6 months prior to Visit 1: acute myocardialinfarction, transient ischemic attack or stroke, hospitalization for anycardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosisand cardiac arrhythmias including paroxysmal (e.g., intermittent). Participants withpersistent atrial fibrillation as defined by continuous atrial fibrillation for atleast 6 months and controlled with a rate control strategy (i.e., selective betablocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy)and stable appropriate level of anticoagulation for at least 6 months may beconsidered for inclusion.
Study Design
Study Description
Connect with a study center
D&H Doral Research Center, LLC
Doral, Florida 33122
United StatesActive - Recruiting
Qway Research, LLC
Hialeah, Florida 33010
United StatesActive - Recruiting
Research Institute of South Florida
Miami, Florida 33173
United StatesActive - Recruiting
Velocity Clinical Research, Gaffney
Greenville, South Carolina 29615
United StatesSite Not Available
Velocity Clinical Research, Spartanburg - Pulmonology
Spartanburg, South Carolina 29303
United StatesSite Not Available
Velocity Clinical Research- Union
Union, South Carolina 29379
United StatesSite Not Available
Elligo Health Research, Inc.
Austin, Texas 78738
United StatesSite Not Available
El Paso Pulmonary Association
El Paso, Texas 79902
United StatesActive - Recruiting
Metroplex Pulmonary and Sleep Center
McKinney, Texas 75069
United StatesActive - Recruiting
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