A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

Launched by UPSTREAM BIO INC. · May 9, 2025

Keywords

ClinConnect Summary

The VALOUR trial is a study designed to assess the long-term safety and effectiveness of a new medication called verekitug (also known as UPB-101) for adults with severe asthma. This trial is open to individuals who have already completed a related study called the VALIANT study. To participate, you need to be between the ages of 65 and 74, have given your informed consent to take part in this research, and use birth control if you are able to become pregnant.

If you join the trial, you will be monitored closely to ensure your safety and to see how well the medication works over time. It’s important to note that if you have certain medical conditions or previous issues from the earlier study, you might not be eligible to participate. While the trial is not yet recruiting participants, it aims to provide valuable information about how verekitug can help those struggling with severe asthma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Completion of the VALIANT study (UPB-CP-04 \[NCT06196879\]) per protocol.
• • 2. 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.
• • 3. Contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. 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).
• • 4. 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.
• • 5. Participants with significant protocol deviations in VALIANT, assessed at the discretion of the Sponsor.
• • 6. 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.