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

Other illness

• 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).
• 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.

Lab values

• 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.

Other

• 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.
• 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.

• Completion of the VALIANT study per protocol. Participants must have not met VALIANT discontinuation criteria and have attended the VALIANT EOS visit.
• 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.