Severe Asthma
Conditions
Interventions
Eligible participants will receive one of the following intervention, assigned in a randomized manner and to be administered sub-cutaneously:
- verekitug (UPB-101) 100 mg every 12 weeks (Q12W)
- verek
Sponsors
Chiba Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF). - Aged 18 to 80 years of age (inclusive) at the time of signing the ICF. - Physician-diagnosed asthma for at least 12 months prior to Visit 1. - Participant has evidence of bronchodilator (BD) reversibility as documented by either historical reversibility (in the 12 months prior to Visit 1) or reversibility during screening. - Documented treatment with a total daily dose of either medium or high dose inhaled costicosteroids (ICS) for at least 3 months. Participants on medium dose ICS must also have been taking at least one additional maintenance asthma controller medication for at least 3 months. - Documented history of asthma exacerbation(s) within 12 months of Visit 1. - Asthma Control Questionnaire-6 (ACQ-6) score >= 1.5 at Visit 1 and randomization. - Participant must have a pre-BD FEV1 value of >=30 % and <=80% predicted at screening. - Minimum compliance with daily diary and background asthma medication(s) as captured in the daily diary during the Run-in Period. - Agrees to follow the required contraceptive techniques/methods. - Female or male participant agrees not to donate eggs or sperm, respectively, for a period of 120 days after the last dose of the study drug intervention or at the Final Visit, whichever occurs last.
Exclusion criteria
Exclusion criteria: - Inpatient hospitalization due to asthma at any time within 4 weeks prior to Visit 1 or during the Screening/Run-in Period. - Previous exposure to verekitug (UPB-101) or known allergy/sensitivity to any of its excipients. - Previous biologics, including those for asthma treatment, for which the appropriate washout period is not fulfilled prior to Visit 1. If the half-life is not known, a 24-week washout period prior to Visit 1 should be applied. - Allergen immunotherapy (unless maintenance dose) within 12 weeks prior to Visit 1 or plans to begin therapy or change dosing during the study. - For participants taking oral corticosteroids (OCS), the dose has not been stable for at least 2 weeks prior to Visit 1 and/or is >10 mg daily, or >20 mg every other day. - Evidence of active or suspected bacterial, viral, fungal, or parasitic infections within 2 weeks prior to Visit 1. - History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy. - Current tobacco smokers, nicotine vapers (including electronic cigarettes), snuff users or participants with a smoking history >=10 pack years. (Former nicotine smokers with a smoking history of <10 pack years, former nicotine vapers and former snuff users must have stopped for at least 6 months prior to Visit 1 to be eligible). - Positive coronavirus disease 2019 (COVID-19) test with lower respiratory tract symptoms within 28 days before Visit 1. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized asthma exacerbation rate (AAER) over 60 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline to Week 60 in Forced Expiratory Volume in 1 Second (FEV1) of Pre-bronchodilator (Pre-BD) - Change from baseline to Week 60 in Fractional exhaled nitric oxide (FeNO) - Change from baseline to Week 60 in asthma Control Questionnaire-6 (ACQ-6) - Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | — |
Countries
Argentina, Bulgaria, Canada, Chile, Czechia, Germany, Italy, Japan, Poland, South Africa, South Korea, Spain, UK, Ukraine, US
Contacts
Public ContactAkiko Chiba
Syneos Health Japan K.K.
Outcome results
None listed