El objetivo principal de este estudio es describir la eficacia de rocatinlimab en la reducción de las exacerbaciones del asma.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants must be between the ages of 18 and 75.
Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.
Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as \> 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist \[LTRA\], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.
Documented history of ≥ 1 asthma exacerbation in the past year prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (\> 250 μg fluticasone propionate or equivalent ICS).
Morning pre-BD FEV1 ≥ 35% and ≤ 90% of predicted normal at the screening visit and day 1 pre-randomization visits.
ACQ-6 score ≥ 1.5 at the day 1 pre randomization visit.

Criterios de exclusión

Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
Any clinically important pulmonary disease other than asthma.
Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of \> 10 pack-years.
Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
Active and non-virally suppressed hepatitis B infection at initial screening,
Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

Ubicaciones

Fundacion Respirar - Centro Medico Dra De Salvo

CABA, Buenos Aires, Argentina

Centro de Osteopatias Medicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion Enfisema para el Estudio y Tratamiento de las Enfermedades Cronicas del Aparato Respirador

Mar del Plata, Buenos Aires, Argentina

Ierim Instituto de Enfermedades Respiratorias e Investigacion Clinica

San Juan Bautista, Buenos Aires, Argentina

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, Argentina

Fundacion Grupo Colaborativo Rosario Investigacion y Prevencion medica

Rosario, Santa Fe Province, Argentina

Centro Integral de Medicina Respiratoria

San Miguel de Tucumán, Tucumán Province, Argentina

Cemer Centro Medico de Enfermedades Respiratorias

Florida, Vicente Lopez, Argentina

Instituto Medico Insares SA

Mendoza, Argentina

Fundacion Scherbovsky