A Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

Korábbi kezelés

• 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.

Laborértékek

• 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.
• 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.

Egyéb

• Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines
• Chronic hypercapnia requiring Bilevel Positive Airway Pressure (BiPAP). Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded.

• 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.