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

Korábbi kezelés

• 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 milligram (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.
• 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.

Más betegség

• History compatible with or diagnosis of a parasitic infection and has not been treated or has not responded to standard of care therapy.

Egyéb

• 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.

• Signed, dated, and received a copy of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF).
• Age 18 to 80 years of age (inclusive) at the time of consent.
• 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 (within 12 months prior to study entry) or reversibility during screening.
• Documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (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 greater than or equal to (\>=) 1.5 at screening and randomization.
• Participant must have a pre-BD FEV1 value of \>=30 percent (%) 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.