Resumen

El propósito de este estudio es evaluar la eficacia y la seguridad de verekitug (UPB-101) en participantes con asma grave. El estudio evaluará la incidencia de exacerbaciones del asma, otros parámetros farmacodinámicos (FD) como la función pulmonar y el control del asma, y la seguridad y tolerabilidad de verekitug (UPB-101) en comparación con placebo.

Descripción detallada

Este es un estudio multicéntrico, aleatorizado, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de verekitug (UPB-101) administrado por vía subcutánea (SC). Un total de aproximadamente 436 participantes adultos con asma grave están planificados para enrolarse y serán aleatorizados en proporción 1:1:1:1 para recibir verekitug (UPB-101) en dosis de 100 mg cada 12 semanas (Q12W), 400 mg cada 24 semanas (Q24W) y 100 mg cada 24 semanas (Q24W), o placebo administrado SC. Para mantener el enmascaramiento de las diferentes dosis, todos los participantes recibirán 2 inyecciones SC en cada visita de dosificación. Este estudio consiste en un período de selección/período de rodaje (aproximadamente 4 semanas), un período de tratamiento (hasta 60 semanas con un mínimo de 24 semanas) y un período de seguimiento (que finaliza aproximadamente 16 semanas después de la última administración de la intervención del estudio).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.
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.

Ubicaciones

CARE: Centro de Alergia y Enfermedades Respiratorias

Buenos Aires, Argentina, Argentina

Fundacion Respirar - Centro Medico Dra. De Salvo

Buenos Aires, Argentina, Argentina

Fundacion Cidea

Caba, Argentina, Argentina

InAER

CABA, Argentina, Argentina

Centro Medico Dharma

Mendoza, Argentina, Argentina

IERIM Instituto de Enfermedades Respiratorias e Investigacion Medica

San Juan Bautista, Buenos Aires, Argentina

Centro Dr. Lazaro Langer Privado Medicina del Aparato Respiratorio

Córdoba, Córdoba Province, Argentina

Centro de Medicina Respiratoria

Concepción del Uruguay, Entre Ríos Province, Argentina

Fundacion Scherbovsky

Mendoza, Mendoza Province, Argentina

INSARES

Mendoza, Mendoza Province, Argentina

Fundacion Estudios Clinicos (FECLIN)

Rosario, Santa Fe Province, Argentina

Instituto Especialidades de la Salud Rosario