A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With … (NCT06196879) | Clinical Trial Compass
CompletedPhase 2
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
United States, Argentina, Bulgaria479 participantsStarted 2024-02-27
Plain-language summary
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 pharmacodynamic (PD) parameters such as lung function and asthma control, and the safety and tolerability of verekitug (UPB-101) compared to placebo.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
* Age 18 to 80 years of age (inclusive) at the time of consent.
* Physician-diagnosed asthma for at least 12 months prior to Visit 1.
* Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (within 12 months prior to study entry) or reversibility during screening.
* Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months.
* Documented history of asthma exacerbation(s) within 12 months of Visit 1.
* Asthma Control Questionnaire-6 (ACQ-6) score greater than or equal to (\>=) 1.5 at screening and randomization.
* Participant must have a pre-BD FEV1 value of \>=30 percent (%) and \<=80% predicted at Screening.
* Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period.
* Agrees to follow the required contraceptive techniques/methods.
* Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.
Exclusion Criteria:
* Inpatient …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.