Severe Asthma
Conditions
Interventions
Those participants in VALIANT who were receiving either 100 mg every 24 weeks (Q24W) or placebo will be randomized in a 1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg every 12 weeks (Q12W
Sponsors
Ikeda Takuji
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Annualized Asthma Exacerbation Rate (AAER) - Change from LTE Baseline in Forced Expiratory Volume in 1 Second (FEV1) - Change from LTE Baseline in Fractional Exhaled Nitric Oxide (FeNO) - Change from LTE Baseline in Asthma Control Questionnaire-6 (ACQ-6) | — |
Countries
Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Italy, Japan, Poland, South Africa, South Korea, Spain, UK, Ukraine, US
Contacts
Public ContactTakuji Ikeda
Syneos Health Japan K.K.
Outcome results
None listed