A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF VEREKITUG (UPB-101) IN ADULT PARTICIPANTS WITH SEVERE ASTHMA (VALIANT)

STUDY OVERVIEW

The VALIANT study, sponsored by Upstream Bio, aims to evaluate the efficacy and safety of Verekitug (UPB-101) in participants with severe asthma. This study will assess the incidence of asthma exacerbations and pharmacodynamic (PD) parameters such as lung function and asthma control and compare the safety and tolerability of Verekitug (UPB-101) to a placebo.

STUDY GOALS

  • Primary Aim: Evaluate the efficacy and safety of Verekitug (UPB-101) in reducing the Annual Asthma Exacerbation Rate (AAER).

  • Secondary Goals: Assess changes in lung function, airway inflammation, asthma control, and monitor adverse events.

LOCATION

INCLUSION CRITERIA

  • Participants aged 18 to 75 years, with signed consent.

  • Documented diagnosis of asthma for at least one year.

  • Evidence of reversible airway constriction.

  • Treatment with medium or high-dose inhaled corticosteroids for at least three months.

  • History of asthma exacerbations within the past 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 entries and asthma medication regimen.

  • 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.