Resumen

Objetivo primario: Evaluar los efectos de SAR440340 con o sin dupilumab, en comparación con placebo, en la reducción de la incidencia de eventos de "pérdida de control del asma" (LOAC). Objetivos secundarios: Evaluar los efectos de SAR440340/REGN3500 y la coadministración de SAR440340 y dupilumab, en comparación con placebo, sobre el volumen espiratorio forzado en 1 segundo (FEV1). Evaluar los efectos de la coadministración de SAR440340 y dupilumab, en comparación con SAR440340 y en comparación con dupilumab, sobre el FEV1. Evaluar la seguridad y tolerabilidad de SAR440340 solo y en coadministración con dupilumab.

Descripción detallada

La duración total del estudio (por participante) fue de aproximadamente 36 semanas, incluidas 4 semanas de selección, 12 semanas de tratamiento y 20 semanas postratamiento.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 70 YearsSexo: ALL

Criterios de inclusión

Adult participants with a physician diagnosis of asthma for at least 12 months based on the Global Initiative for Asthma (GINA) 2017 Guidelines.
Participants with existing treatment with medium to high dose ICS (greater than or equal to \[\>=\] 250 microgram (mcg) of fluticasone propionate twice a day (BID) or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or clinically comparable) in combination with a LABA as second controller for at least 3 months with a stable dose \>=1 month prior to Visit 1.
Participants with pre-bronchodilator FEV1 greater than (\>) 40 percent (%) of predicted normal at Visit 1/Screening. Pre-bronchodilator FEV1 \>=50% but less than or equal to (\<=) 85% of predicted normal at Visit 2/Baseline.
Participants with reversibility of at least 12% and 200 milliliters (mL) in FEV1 after administration of 2 to 4 puffs (200-400 microgram \[µg\]) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criteria within 12 months prior to Visit 1 or documented positive response to methacholine challenge (a decrease in FEV by 20% \[PC20\] of less than \[\<\] 8 milligram per milliliter \[mg/mL\]) within 12 months prior to Visit 1/Screening is considered acceptable to meet this inclusion criterion.
Participants had experienced, within 1 year prior to Visit 1, any of the following events at least once:
Treatment with a systemic steroid (oral or parenteral) for worsening asthma.
Hospitalization or emergency medical care visit for worsening asthma.
Signed written informed consent.

Criterios de exclusión

Participants \<18 years or \>70 years of age (i.e., have reached the age of 71 at the screening visit).
Participants with body mass index (BMI) \<16.
Chronic lung disease (for example, chronic obstructive pulmonary disease \[COPD\], or idiopathic pulmonary fibrosis \[IPF\]), which might impair lung function.
History of life threatening asthma (i.e., severe exacerbation that required intubation).
Co-morbid disease that might interfere with the evaluation of investigational medicinal product (IMP).
Participants with any of the following events within the 4 weeks prior to their Screening Visit 1:
Treatment with 1 or more systemic (oral and/or parenteral) steroid bursts for worsening asthma;
Hospitalization or emergency medical care visit for worsening asthma.
Asthma Control Questionnaire 5-question version (ACQ-5) score \<1.25 or \>3.0 at Visit 2/randomization. During the screening period, an ACQ-5 of up to \<=4 was acceptable.
Anti-immunoglobulin E (IgE) therapy (e.g., omalizumab \[Xolair®\]) within 130 days prior to Visit 1 or any other biologic therapy (including anti interleukin-5 \[anti-IL5\] monoclonal antibodies \[mAb\]) or systemic immunosuppressant (e.g., methotrexate) to treat inflammatory disease or autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever was longer.
Participants with a history of a systemic hypersensitivity reaction to a biologic drug.
Participants on or initiation of bronchial thermoplasty within 2 years prior to Visit 1 or plan to begin therapy during the screening period or the randomized treatment period.
Current smoker or cessation of smoking within the 6 months prior to Visit 1.
Previous smoker with a smoking history \>10 pack-years.
The above information is 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

Dupilumab

Pharmaceutical form: Solution for Injection, Route of administration: SC

drug

Fluticasone or Fluticasone/salmeterol combination

Pharmaceutical form: Aerosol, dry powder, Route of administration: Inhaled

drug

Placebo for SAR440340

Pharmaceutical form: Solution for Injection, Route of administration: SC

drug

Placebo for dupilumab

Pharmaceutical form: Solution for Injection, Route of administration: SC

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

SAR440340

Dupilumab

Fluticasone or Fluticasone/salmeterol combination

Placebo for SAR440340

Placebo for dupilumab

Ubicaciones

Investigational Site Number 0320001

Investigational Site Number 0320003

Investigational Site Number 0320002

Investigational Site Number 0320004

Investigational Site Number 0320005

Patrocinadores