Last updated 19 days ago
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALIANT)
436 patients around the world
Available in Chile, Argentina
This is a multicenter, randomized, placebo-controlled, parallel group study to assess the
efficacy and safety of verekitug (UPB-101) administered subcutaneously (SC). A total of
approximately 436 adult participants with severe asthma are planned for enrolment and
will be randomized in a 1:1:1:1 ratio to receive verekitug (UPB-101) at doses of 100 mg
every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), and 100 mg every 24 weeks (Q24W), or
placebo administered SC. In order to maintain the blinding of different doses, all
participants will receive 2 SC injections at each dosing visit. This study consists of a
Screening/Run-In Period (approximately 4 weeks), Treatment Period (up to 60 weeks with a
minimum of 24 weeks) and Follow-up Period (ending approximately 16 weeks after the last
administration of study intervention).
Upstream Bio Inc.
10Research sites
436Patients around the world
This study is for people with
Asthma
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- 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 75 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.
- 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 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.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.
Sites
InAER - Investigaciones en Alergia y Enfermedades Respiratorias - CABA, Buenos Aires
Recruiting
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Recruiting
Fundación CIDEA - Buenos Aires
Recruiting
Fundación Respirar
Recruiting
Instituto INSARES - Mendoza
Recruiting
Consultorios Médicos Dr. Isaac Scherbovsky - Mendoza
Recruiting
Instituto de Investigaciones en Patologías Respiratorias SRL - Tucumán
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Centro de Investigaciones Médicas Respiratorias (CIMER) - Chile
Recruiting
Icegclinic Research & Care
Recruiting
StudyVALIANT
SponsorUpstream Bio Inc.
Study typeInterventional
Conditions
Asthma
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06196879
