A Phase 2b Study to Assess the Efficacy and Safety of Verekitug in Participants With COPD

Launched by UPSTREAM BIO INC. · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of a new medication called verekitug in people who have moderate to severe Chronic Obstructive Pulmonary Disease (COPD), a long-term lung disease that makes it hard to breathe. The study aims to see if this medication can help improve symptoms and lung function in participants who have been diagnosed with COPD for over a year and have a history of smoking.

To participate, individuals must be at least 18 years old, have a confirmed COPD diagnosis, and meet specific criteria related to their lung function and treatment history. For instance, they should have been using certain prescribed medications (like inhalers) consistently for at least three months before the trial starts. Participants will undergo regular check-ups to monitor their health and how well the medication is working. It's important to note that the trial is not currently recruiting participants, but those who may be interested should keep an eye out for future announcements.

Gender

ALL

Eligibility criteria

• 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.