Resumen

Objetivo primario: Investigar los efectos de SAR440340 (anticuerpo monoclonal [mAb] anti-interleucina-33 [IL-33]) en comparación con placebo sobre la tasa anualizada de exacerbaciones agudas moderadas a graves de la EPOC (EAEPOC) durante un tratamiento de hasta 52 semanas. * Las exacerbaciones moderadas fueron registradas por el investigador y definidas como EAEPOC que requieren corticosteroides sistémicos (como intramusculares, intravenosos u orales) y/o antibióticos. * Las exacerbaciones graves fueron registradas por el investigador y definidas como EAEPOC que requieren hospitalización, visita de atención médica de emergencia o que resultan en muerte. Objetivos secundarios: Investigar los efectos de SAR440340 en comparación con placebo sobre la mejora de la función respiratoria, evaluada mediante el volumen espiratorio forzado en 1 segundo (VEF1) pre-broncodilatador. Evaluar los efectos de SAR440340 en comparación con placebo sobre el VEF1 post-broncodilatador. Evaluar los efectos de SAR440340 en comparación con placebo sobre la duración desde el inicio hasta el primer evento de EAEPOC moderada o grave. Evaluar los efectos de SAR440340 en comparación con placebo sobre la seguridad y tolerabilidad.

Descripción detallada

La participación en el estudio para cada participante fue de un total de 46 a 76 semanas, incluyendo un período de selección de 10 días a 4 semanas, un período de tratamiento con el producto médico en investigación (PMI) de 24 a 52 semanas y un período posterior al tratamiento con el PMI de 20 semanas.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Participants with a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 1 year (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition).
Participants with moderate-to-severe COPD (post-bronchodilator forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] less than \[\<\] 70 percent (%) and post-bronchodilator FEV1% predicted \<80%, but greater than equal to \[\>=\] 30%).
Participants with COPD assessment test (CAT) score \>=10 at Screening.
Participants with reported history of signs and symptoms of chronic bronchitis (chronic productive cough for 3 months in the year up to screening in a participant in whom other causes of chronic cough \[e.g., gastroesophageal reflux, chronic rhinosinusitis, bronchiectasis\] had been excluded).
Participants with a documented history (e.g., medical record verification) of \>=2 moderate exacerbations or \>=1 severe exacerbation within the year prior to screening. A moderate exacerbation was defined as an acute exacerbation of COPD (AECOPD) requiring systemic corticosteroids (oral, intravenous, or intramuscular) and/or treatment with antibiotics (however, use of antibiotics alone does not qualify as a "moderate exacerbation" unless documentation was available that use of antibiotics was necessary for treatment of worsening symptoms of COPD). A severe exacerbation was defined as an AECOPD that required a hospitalization.
Participants with standard of care background therapy, for 3 months and at a stable dose for at least 1 month, including either:
Double therapy: Long acting beta agonist (LABA) + Long acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) + LABA or ICS + LAMA.
or
Triple therapy: LABA + LAMA + ICS.
Current or former smokers with a smoking history of \>=10 packs/year.

Criterios de exclusión

Concomitant severe diseases or diseases for which the use of ICS (e.g., active pulmonary tuberculosis, etc.) or LABA were contraindicated (e.g., diagnosis of a history of significant cardiovascular diseases, insulin-dependent diabetes mellitus, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia).
Use of injectable glucocorticosteroids or oral systemic glucocorticosteroids within previous 1 month or more than 4 courses of intravenous glucocorticosteroids within the previous 6 months.
Participants with bronchial thermoplasty procedure (up to 3 years prior to Visit 1).
A current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines.
Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, eosinophilic granulomatosis with polyangiitis, significant sleep apnea on Bilevel Positive Airway Pressure, etc.) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
Diagnosis of α-1 anti-trypsin deficiency.
Advanced COPD with need for chronic (greater than \[\>\] 15 hours/day) oxygen support.
Participant with a moderate or severe acute exacerbation of COPD event within previous 4 weeks.
A participant who has experienced an upper or lower respiratory tract infection within previous 4 weeks.
Prior history of or planned pneumonectomy or lung volume reduction surgery.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Intervenciones

drug

SAR440340

Pharmaceutical form: Solution for injection; Route of administration: SC

drug

Placebo

Pharmaceutical form: Solution for injection; Route of administration: SC

drug

Any Inhaled Corticosteroids as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled

drug

Any Long Acting Beta Agonist as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

drug

Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled

drug

Any short-acting β agonist as prescribed by treating physician as standard of care

Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled

Ubicaciones

Investigational Site Number 0320001

Buenos Aires, Argentina

Investigational Site Number 0320005

Caba, Argentina

Investigational Site Number 0320002

Caba, Argentina

Investigational Site Number 0320004

Caba, Argentina

Investigational Site Number 0320006

Quilmes, Argentina

Investigational Site Number 0320003

Rosario, Argentina

Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de prueba de concepto (PoC), para evaluar la eficacia, seguridad y tolerabilidad de SAR440340 en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) moderada a grave

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

SAR440340

Placebo

Any Inhaled Corticosteroids as prescribed by treating physician as standard of care

Any Long Acting Beta Agonist as prescribed by treating physician as standard of care

Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care

Any short-acting β agonist as prescribed by treating physician as standard of care

Ubicaciones

Investigational Site Number 0320001

Investigational Site Number 0320005

Investigational Site Number 0320002

Investigational Site Number 0320004

Investigational Site Number 0320006

Investigational Site Number 0320003

Patrocinadores