A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
STUDY OVERVIEW
The purpose of this study sponsored by Upstream Bio Inc. is to evaluate the efficacy and safety of verekitug (UPB-101) in participants with severe asthma. The study will evaluate the incidence of asthma exacerbations, other pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
STUDY GOALS
The primary aim of this study is to evaluate the efficacy and safety of Verekitug (UPB-101) for severe asthma. Reduction in Annual Asthma Exacerbation Rate (AAER). Changes in lung function, airway inflammation, asthma control, and adverse events.
LOCATION
El Paso, Texas: El Paso Pulmonary Association
INCLUSION CRITERIA
Participants must be between 18 and 75 years old and provide signed consent.
They must have a documented diagnosis of asthma for at least a year.
Evidence of reversible airway constriction.
Documented treatment with medium or high-dose inhaled corticosteroids for at least three months.
A history of asthma exacerbations within the last year.
ACQ-6 score of 1.5 or higher at screening.
Pre-treatment lung function between 30% and 80% of the predicted value.
Compliance with daily diary and asthma medication.
Willingness to use contraception and refrain from egg or sperm donation during and after the study.
exclusion criteria
Recent hospitalization due to asthma.
Allergy to the study drug or its components.
Recent use of certain asthma medications.
Allergen immunotherapy within the last 12 weeks.
Unstable oral corticosteroid dosage.
Evidence of certain infections.
History of untreated parasitic infection.
Current or recent tobacco use.
Recent positive COVID-19 test with respiratory symptoms.
Pregnancy, breastfeeding, or unwillingness to use contraception during the study.
For more information, visit ClinicalTrials.gov.