Resumen

El propósito de este ensayo clínico es conocer la seguridad y los efectos del medicamento en estudio (denominado PF-07275315) para el tratamiento potencial del asma moderada a grave. El asma es una enfermedad que dificulta la respiración, lo que repercute negativamente en la calidad de vida y el funcionamiento de las personas afectadas. Este estudio busca participantes que: * Tengan entre 18 y 70 años. * Padezcan asma moderada a grave durante al menos 12 meses que no esté bien controlada. * Hayan estado tomando su(s) tratamiento(s) de mantenimiento habitual(es) para el asma durante los últimos 12 meses. Todos los participantes recibirán PF-07275315 o un placebo. Un placebo no contiene ningún medicamento, pero tiene exactamente el mismo aspecto que el medicamento en estudio. PF-07275315 o placebo se administrará mediante varias inyecciones en el centro clínico a lo largo de 12 semanas. Compararemos las experiencias de las personas que reciben PF-07275315 con las de quienes no lo reciben. Esto nos permitirá determinar si PF-07275315 es seguro y eficaz. Los participantes estarán involucrados en este estudio durante aproximadamente 7,5 meses. Durante este tiempo, realizarán 9 visitas al centro del estudio.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Must meet the following asthma criteria:
History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit.
At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to \<80% of predicted normal values.
Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
ACQ-5 score of ≥1.5 at screening visit and prior to randomization.
Body mass index between 18 40 kg/m2 at screening.

Criterios de exclusión

Medical Conditions:
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis
Diagnosed with any of the following acute or chronic infections or infection history:
Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;
Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1.
Prior/Concomitant Therapy:
Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4, IL-13, IL-33/ST2, IL-4Rα, TSLP, IL-5, OX40/OX40L or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.
Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.
Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
Bronchial thermoplasty within the previous 24 months.
Prior/Concurrent Clinical Study Experience:
Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Ubicaciones

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

NOT_YET_RECRUITING

Investigaciones en Patologias Respiratorias

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

NOT_YET_RECRUITING

Fundacion Scherbovsky

Mendoza, Argentina

RECRUITING

Instituto de Salud Respiratoria

Mendoza, Argentina

RECRUITING

Un estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, con rango de dosis, para investigar la eficacia y seguridad de PF-07275315 en participantes adultos con asma moderada a grave inadecuadamente controlada

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

PF-07275315

Placebo

Ubicaciones

Fundación Respirar

Investigaciones en Patologias Respiratorias

Centro de Investigaciones Metabólicas (CINME)

Fundacion Scherbovsky

Instituto de Salud Respiratoria

Patrocinadores

Contactos

Pfizer CT.gov Call Center