RecruitingPhase 2NCT06966479
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
A Long-Term Extension Study to Evaluate Safety and Efficacy of Verekitug (UPB-101) in Adult Participants With Severe Asthma Who Completed the VALIANT Trial
Sponsor
Upstream Bio Inc.
Enrollment
436 participants
Start Date
May 21, 2025
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria6
- 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.
- 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.
Interventions
DRUGVerekitug
Verekitug subcutaneous injection.
DRUGPlacebo
Verekitug matching placebo.
Locations(84)
View Full Details on ClinicalTrials.gov
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NCT06966479
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