Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Upstream Bio Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
