This trial is not actively recruiting.
This trial has completed recruitment on this platform, and is no longer accepting new referrals.
VALIANT Study
About the VALIANT Study
The purpose of this study 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 parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
Verekitug is a recombinant fully human immunoglobulin G1 monoclonal antibody designed to block the thymic stromal lymphopoietin receptor (TLSPR) and thus inhibit TSLP-driven inflammation, a pathway implicated in asthma.
Estimated Enrollment
Up to 436 participants
Phase
2Eligibility Criteria
Participants must:
Inclusion criteria
Participants must
- Be 18 to 80 years of age and diagnosed with asthma for at least 12 months
- Be currently or recently treated with inhaled corticosteroids (ICS) for at least 3 months
- Have a documented history of asthma exacerbation(s) within the last 12 months
- Have a body mass index (BMI) between 18 and 40 kg/m2
Participants must not:
Exclusion criteria
Participants must not
- Be pregnant, breastfeeding, or planning to become pregnant
- Have used nicotine containing products (including e-cigarettes) in the past 6 months
- Be in another clinical study or have been treated with an investigational drug in the last 28 days
Participants must:
Inclusion criteria
Participants must
- Be 18 to 80 years of age and diagnosed with asthma for at least 12 months
- Be currently or recently treated with inhaled corticosteroids (ICS) for at least 3 months
- Have a documented history of asthma exacerbation(s) within the last 12 months
- Have a body mass index (BMI) between 18 and 40 kg/m2
Participants must not:
Exclusion criteria
Participants must not
- Be pregnant, breastfeeding, or planning to become pregnant
- Have used nicotine containing products (including e-cigarettes) in the past 6 months
- Be in another clinical study or have been treated with an investigational drug in the last 28 days
About the Condition
Asthma is a common respiratory disease characterized by chronic airway inflammation that is often underdiagnosed and under-treated. For some people, asthma can simply be a nuisance, for others it can interfere with daily life and potentially even be life-threatening.
Severe asthma is defined as asthma that remains uncontrolled despite optimized treatment with high-dose inhaled corticosteroids or that requires high-dosed inhaled corticosteroids to prevent symptoms from becoming uncontrolled.
It is estimated that approximately 90% of people with severe asthma are eligible for treatment with a class of medicines called biologics, but only 440,000 patients are currently treated with biologics, suggesting more than 80% of eligible patients are not being optimally treated. Key areas of unmet need for people living with severe asthma include improved control of exacerbations and symptoms and reduced treatment burden (e.g. need for frequent injections).
Study Locations
Sites are located in the cities/states identified with the red pin:
See if You are Eligible
What Will Happen in this Study
Participants will be assigned to one of four groups to receive the study drug (verekitug (UPB-101)), administered subcutaneously (injection), at a dose of 100 mg every 12 weeks (group A), 400 mg every 24 weeks (group B), 100 mg every 12 weeks (group C), or placebo administered subcutaneously (group D). To maintain the blinding of different doses, all participants will receive 2 subcutaneous injections at each dosing visit every 12 weeks.
The total study duration for each participant will be approximately 8 to 16 months including:
- Screening/Run-In Period: approximately 4 weeks
- Study Treatment Period: up to 60 weeks with a minimum of 24 weeks
- Follow-up Period: ending approximately 16 weeks after the last administration of study intervention
