A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)

JRCT ID: jRCT2031240070

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe Asthma
• Date of first enrollment: 13/05/2024
• Target sample size: 28
• Countries of recruitment: Argentina,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,Czechia,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,UK,Japan,US,Japan
• Study type: Interventional

Intervention(s)

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)
- verekitug 400 mg every 24 weeks (Q24W)
- verekitug 100 mg Q24W
- placebo administered SC
In order to maintain the blinding of different doses, all participants will receive 2 SC injections at each dosing visit.

Outcome(s)

• Primary Outcome: Annualized asthma exacerbation rate (AAER) over 60 weeks of treatment

Secondary Outcome

- 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 75 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.

Exclude 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 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.

Related Information

• Primary Sponsor: Hirano Rie
• Secondary ID(s): NCT06196879