A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe As… (NCT06966479) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
United States, Argentina, Bulgaria396 participantsStarted 2025-05-21
Plain-language summary
The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
Who can participate
Age range
18 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
. Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol.
. Participant has signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) for the LTE study.
. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
. Abnormal medical history, physical finding, or safety finding that in the opinion of the Investigator may obscure the study data or interfere with the participant's safety.
. Any clinical laboratory test result outside of the reference ranges considered by the Investigator as clinically significant and that may obscure the study data or interfere with the participant's safety.
. Participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction).
. Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active.
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.
1This trial is in Phase 2 and is primarily measuring safety — how much do we actually know so far about whether verekitug is safe and effective for severe asthma compared to treatments I might already be on?
2Since the trial is listed as 'active, not recruiting,' does that mean enrollment is closed, and if so, are there other similar studies or trials testing verekitug that might still be open to me?
3The study is tracking serious adverse events as a main outcome — based on what's known so far about how verekitug works, what types of side effects should I and my family be watching out for?
4How does participating in a long-term safety study like this one differ from simply starting a standard biologic treatment for severe asthma — and given my specific situation, which path makes more sense for me right now?
5If I were enrolled in a study like this, what would the time commitment and follow-up schedule typically look like, and how might that fit with managing my asthma care day to day?
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.
What they're measuring
1
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
. Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
. Participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the Investigator or has any disorder that may compromise their ability to give informed consent.