RECRUITING

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

Conditions

Chronic Obstructive Pulmonary Disease Verekitug UPB-101 Emphysema Chronic Bronchitis Thymic Stromal Lymphopoetin Receptor Lung Inflammation Biologic Monoclonal Antibody VENTURE

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-08

Study Completion:2029-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06981078

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Upstream Bio Clinical Trials Information (Privacy Notice: https://upstreambio.com/privacy-policy/)

CONTACT

888-446-3130

clinicaltrials@upstreambio.com

Principal Investigator

Justin Salciccioli, MD

STUDY_DIRECTOR

Upstream Bio

Study Locations (Sites)

D&H Doral Research Center, LLC

Doral, Florida, 33122

United States

Research Institute of South Florida

Miami, Florida, 33173

United States

Velocity Clinical Research, Gaffney

Greenville, South Carolina, 29615

United States

Elligo Health Research, Inc.

Austin, Texas, 78738

United States

El Paso Pulmonary Association

El Paso, Texas, 79902

United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, 75069

United States

Collaborators and Investigators

Sponsor: Upstream Bio Inc.

Justin Salciccioli, MD, STUDY_DIRECTOR, Upstream Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2029-08

Study Record Updates

Study Start Date2025-08

Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

Verekitug
UPB-101
Chronic Obstructive Pulmonary Disease
Emphysema
Chronic Bronchitis
Thymic Stromal Lymphopoetin Receptor
Lung Inflammation
Biologic
Monoclonal Antibody
VENTURE

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease