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Clinical Trials in the UK / NCT06981078
Active, not recruiting Phase 2

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

NCT06981078 · tracked via the Priya Life Science UK tracker
Sponsor
Upstream Bio Inc.
Phase
Phase 2
Started
2025-07-02
Last updated
2026-07-20

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

VerekitugPlacebo

Verekitug: Verekitug (UPB-101) formulated solution

Placebo: Matching Placebo to Verekitug (UPB-101)

Study summary

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)

Trial sites (242)

FacilityCityRegionStatus
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 Savannah Georgia
Christie Clinic, LLC Champaign Illinois
Velocity Clinical Research-Rockville Rockville Maryland
Chesapeake Clinical Research, Inc White Marsh Maryland
HealthPartners Saint Paul Minnesota
American Health Research, Inc. Charlotte North Carolina
Velocity Clinical Research, Anderson Anderson South Carolina
SleepMed Inc. Columbia South Carolina
Velocity Clinical Research, Gaffney Greenville South Carolina
Velocity Clinical Research, Spartanburg - Pulmonology Spartanburg South Carolina
Velocity Clinical Research- Union Union South Carolina
El Paso Pulmonary Association El Paso Texas
Victorium Clinical Research Houston Texas
Synergy Groups Medical LLC Houston Texas
Synergy Groups Medical LLC Houston Texas
Metroplex Pulmonary and Sleep Center McKinney Texas
Synergy Groups Medical LLC Missouri City Texas
Velocity Clinical Research - Suffolk Suffolk Virginia
CARE - Centro de Alergia y Enfermedades Respiratorias Buenos Aires Buenos Aires
Consultorios Médicos Dr. Doreski Buenos Aires Buenos Aires
Centro de Medicina Respiratoria Concepción del Uruguay Entre Ríos Province
Fundacion Scherbovsky Mendoza Mendoza Province
Fundacion Estudios Clinicos (FECLIN) Rosario Santa Fe Province
Instituto Médico Fundación Grupo Colaborativo Rosario Invest Rosario Santa Fe Province
Medical Center Pulmo-2018 EOOD Haskovo Haskovo
Medical Center Medconsult Pleven, Lovech branch Lovech Lovech
MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics Montana Montana
SHLTTRPD "Sveta Petka Balgarska" EOOD Velingrad Pazardzhik
Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOOD Dupnitsa Pernik

+ 202 more sites — see the full list on the official registry below.

More Upstream Bio Inc. trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT06981078 on ClinicalTrials.gov ↗ ← All trials in the UK