Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT06981078

PHASE2

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

Sponsor: Upstream Bio Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

666

Start Date

2025-07-02

Completion Date

2027-11

Last Updated

2026-07-20

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Verekitug

Verekitug (UPB-101) formulated solution

OTHER

Placebo

Matching Placebo to Verekitug (UPB-101)

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.

Locations (242)

Kern Research Inc.

Bakersfield, California, United States

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

Synergy Groups Medical LLC

Houston, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Synergy Groups Medical LLC

Missouri City, Texas, United States

Velocity Clinical Research - Suffolk

Suffolk, Virginia, United States

CARE - Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Buenos Aires, Argentina

Consultorios Médicos Dr. Doreski

Buenos Aires, Buenos Aires, Argentina

Centro de Medicina Respiratoria

Concepción del Uruguay, Entre Ríos Province, Argentina

Fundacion Scherbovsky

Mendoza, Mendoza Province, Argentina

Fundacion Estudios Clinicos (FECLIN)

Rosario, Santa Fe Province, Argentina

Instituto Médico Fundación Grupo Colaborativo Rosario Invest

Rosario, Santa Fe Province, Argentina

Medical Center Pulmo-2018 EOOD

Haskovo, Haskovo, Bulgaria

Medical Center Medconsult Pleven, Lovech branch

Lovech, Lovech, Bulgaria

MEDICAL CENTER HERA EOOD; Office of Pulmonology and Phtisiatrics

Montana, Montana, Bulgaria

SHLTTRPD "Sveta Petka Balgarska" EOOD

Velingrad, Pazardzhik, Bulgaria

Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOOD

Dupnitsa, Pernik, Bulgaria

Dr. Filip Shterev IAPSMCPP EOOD

Plovdiv, Plovdiv, Bulgaria

Medical Center Etika Ambulatory For Specialized Outpatient Medical Care OOD

Plovdiv, Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment "St. Panteleimon "- Plovdiv

Plovdiv, Plovdiv, Bulgaria

Medical Center Prolet EOOD - Pulmonary, Allergy Diseases

Rousse, Ruse, Bulgaria

Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse EOOD

Rousse, Ruse, Bulgaria

Diagnostic consultative center 1 -Sliven

Sliven, Sliven, Bulgaria

MHAT Sliven to MMA Sofia

Sliven, Sliven, Bulgaria

Medical Center Excelsior OOD, Base 2

Sofia, Sofia, Bulgaria

Acibadem City Clinic Tokuda University Hospital EAD

Sofia, Sofia, Bulgaria

First Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, Bulgaria

Specialized Hospital For Active Treatment Of Pulmonary Diseases - Sofia EOOD

Sofia, Sofia-Grad, Bulgaria

National Multiprofile Transport Hospital (NMTB) - Internal Diseases

Sofia, Sofia-Grad, Bulgaria

Medical Center Excelsior OOD, Base 1

Sofia, Sofia-Grad, Bulgaria

Medical Center Hera

Sofia, Sofia-Grad, Bulgaria

DCC Convex EOOD

Sofia, Sofia-Grad, Bulgaria

Medical Center for Outpatient Care Preventsia 2000

Stara Zagora, Stara Zagora, Bulgaria

Medical Center - Zdrave1

Kozloduy, Vratsa, Bulgaria

Clinica Fundacion Medica San Cristobal

Vitacura, Santiago Metropolitan, Chile

Centro de Investigación de Enfermedades Respiratorias e Inmunológicas

Viña del Mar, Valparaiso, Chile

EDUMED, s.r.o

Broumov, Hradec Králové Region, Czechia

Plicni ambulance Alveolus s.r.o.

Poruba, Moravian-Silesian Region, Czechia

MEDICON a.s. - Plicni oddeleni

Prague, Praha, Hlavní Mesto, Czechia

Privatni plicni ambulance, s.r.o.

Prague, Praha, Hlavní Mesto, Czechia

Plicni ambulance Rokycany

Rokycany, Rokycany, Czechia

MUDr. Pavlisova Ilona s.r.o.

Miroslav, South Moravian, Czechia

MUDr. I. Cierna Peterova s.r.o.

Brandýs nad Labem, Stredoceský Kraj, Czechia

Plicni ambulance Kralupy s.r.o.

Kralupy nad Vltavou, Stredoceský Kraj, Czechia

Plicni stredisko Teplice s.r.o. - Plicni ordinace

Teplice, Ústí nad Labem Region, Czechia

Pneumologie Varnsdorf s.r.o.

Varnsdorf, Ústí nad Labem Region, Czechia

LTD "High Technology Hospital Medcenter"

Batumi, Adjara, Georgia

LTD Clinic Rustavi

Rustavi, Hvemo Kartli, Georgia

A. Aladashvili clinic LLC