Resumen

Este es un estudio de fase 2, de grupos paralelos, global, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de rango de dosis, de cuatro brazos, para tratamiento. El propósito de este estudio es evaluar la eficacia, seguridad y tolerabilidad de la terapia complementaria con amlitelimab en participantes adultos con asma de moderada a severa. Los detalles del estudio incluyen: * La duración del estudio (por participante) será de aproximadamente 76 semanas para los participantes que no ingresen al estudio de seguridad a largo plazo (SLP) y de aproximadamente 64 semanas para los participantes que ingresen al estudio de SLP. * La duración del tratamiento aleatorizado será de aproximadamente 60 semanas. * El número programado de visitas será de 13.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist \[LABA\], leukotriene receptor antagonist \[LTRA\], long-acting muscarinic antagonist \[LAMA\], methylxanthines) for at least 3 months.
≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
Participants with pre-BD forced expiratory volume in 1 second (FEV1) \> 40% and \< 80% of predicted normal at the screening visit.
item ACQ-5 score \>1.5 at randomization.
Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
Weight ≥40 kg and ≤150 kg at the randomization visit.

Criterios de exclusión

Participants are excluded from the study if any of the following criteria apply:
Chronic lung disease other than asthma.
Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of \>10 pack-years.
Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
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; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
Active infection or history of clinically significant infection
Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Active or latent tuberculosis (TB)
A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured \>3 years prior to baseline).
History of solid organ transplant.
Hepatitis B, C or HIV.
Pregnant or breastfeeding.
History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ubicaciones

Investigational Site Number : 0320001

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320002

CABA, Buenos Aires, Argentina

Investigational Site Number : 0320008

La Plata, Buenos Aires, Argentina

Investigational Site Number : 0320009

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320007

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320003

Ciudad Autonoma Buenos Aires, Argentina

Estudio aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, de rango de dosis, para evaluar la eficacia, seguridad y tolerabilidad de amlitelimab subcutáneo en participantes adultos con asma de moderada a severa

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Amlitelimab

Placebo

Ubicaciones

Investigational Site Number : 0320001

Investigational Site Number : 0320002

Investigational Site Number : 0320008

Investigational Site Number : 0320009

Investigational Site Number : 0320006

Investigational Site Number : 0320007

Investigational Site Number : 0320005

Investigational Site Number : 0320004

Investigational Site Number : 0320003

Patrocinadores