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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT06981078

Run by

Upstream Bio Inc.

People needed

666

Starts

2025-07-02

Expected to finish

2027-11-01

Last updated by the study team

2026-07-20

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PulmoCrit Associates — Encino, California, United States
• Torrance Clinical Research Institute — Lomita, California, United States
• Dream Team Clinical Research — Pomona, California, United States
• Apex Clinical Research — San Diego, California, United States
• Allianz Research Institute — Westminster, California, United States
• D&H Doral Research Center, LLC — Doral, Florida, United States
• Qway Research, LLC — Hialeah, Florida, United States
• Finlay Medical Research — Miami, Florida, United States
• MplusM - ITB Research — Miami, Florida, United States
• Florida Institute for Clinical Research,LLC — Orlando, Florida, United States
• Velocity Clinical Research-Savannah - Internal Medicine — Savannah, Georgia, United States
• Christie Clinic, LLC — Champaign, Illinois, United States
• Velocity Clinical Research-Rockville — Rockville, Maryland, United States
• Chesapeake Clinical Research, Inc — White Marsh, Maryland, United States
• HealthPartners — Saint Paul, Minnesota, United States
• American Health Research, Inc. — Charlotte, North Carolina, United States
• Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
• SleepMed Inc. — Columbia, South Carolina, United States
• Velocity Clinical Research, Gaffney — Greenville, South Carolina, United States
• Velocity Clinical Research, Spartanburg - Pulmonology — Spartanburg, South Carolina, United States
• Velocity Clinical Research- Union — Union, South Carolina, United States
• El Paso Pulmonary Association — El Paso, Texas, United States
• Victorium Clinical Research — Houston, Texas, United States
• Synergy Groups Medical LLC — Houston, Texas, United States
• Kern Research Inc. — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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