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Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

7 de junio de 2017 actualizado por: Sanofi

Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy

Primary Objective:

To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma.

Secondary Objectives:

  • To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
  • To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The total duration of the study period per participant was 20-22 weeks broken down as follows:

  • Screening period: up to 14 days,
  • Treatment period: 12 weeks,
  • Follow-up period: 6-8 weeks.

Tipo de estudio

Intervencionista

Inscripción (Actual)

104

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Anaheim, California, Estados Unidos, 92804
        • Investigational Site Number 840047
      • Long Beach, California, Estados Unidos, 90806
        • Investigational Site Number 840046
      • Los Angeles, California, Estados Unidos, 90025
        • Investigational Site Number 840032
      • Los Angeles, California, Estados Unidos, 90048
        • Investigational Site Number 840036
      • Mission Viejo, California, Estados Unidos, 92691
        • Investigational Site Number 840005
      • Orange, California, Estados Unidos, 92868
        • Investigational Site Number 840007
      • Riverside, California, Estados Unidos, 92506
        • Investigational Site Number 840048
      • Rolling Hills Estates, California, Estados Unidos, 90274
        • Investigational Site Number 840035
      • San Francisco, California, Estados Unidos, 94143
        • Investigational Site Number 840041
      • San Francisco, California, Estados Unidos, 94143
        • Investigational Site Number 840042
      • San Jose, California, Estados Unidos, 95117
        • Investigational Site Number 840039
      • Santa Rosa, California, Estados Unidos, 95405
        • Investigational Site Number 840024
      • Stockton, California, Estados Unidos, 95207
        • Investigational Site Number 840002
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907
        • Investigational Site Number 840031
      • Denver, Colorado, Estados Unidos, 80206
        • Investigational Site Number 840011
      • Denver, Colorado, Estados Unidos, 80230
        • Investigational Site Number 840017
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Investigational Site Number 840026
    • Florida
      • Tallahassee, Florida, Estados Unidos, 32308
        • Investigational Site Number 840044
      • Tampa, Florida, Estados Unidos, 33612
        • Investigational Site Number 840029
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46208
        • Investigational Site Number 840028
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52240
        • Investigational Site Number 840038
    • Kansas
      • Overland Park, Kansas, Estados Unidos, 66210
        • Investigational Site Number 840021
    • Kentucky
      • Owensboro, Kentucky, Estados Unidos, 42303
        • Investigational Site Number 840053
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Investigational Site Number 840014
    • Massachusetts
      • North Dartmouth, Massachusetts, Estados Unidos, 02747
        • Investigational Site Number 840015
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Investigational Site Number 840003
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Investigational Site Number 840010
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Investigational Site Number 840006
      • Saint Louis, Missouri, Estados Unidos, 63141
        • Investigational Site Number 840013
    • Montana
      • Bozeman, Montana, Estados Unidos, 59718
        • Investigational Site Number 840022
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68131
        • Investigational Site Number 840025
      • Papillion, Nebraska, Estados Unidos, 27103
        • Investigational Site Number 840008
    • New Jersey
      • Princeton, New Jersey, Estados Unidos, 08540
        • Investigational Site Number 840018
    • North Carolina
      • Winston-Salem, North Carolina, Estados Unidos, 27157-1071
        • Investigational Site Number 840004
    • Ohio
      • Sylvania, Ohio, Estados Unidos, 43560
        • Investigational Site Number 840023
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Investigational Site Number 840045
    • Oregon
      • Lake Oswego, Oregon, Estados Unidos, 97035
        • Investigational Site Number 840001
      • Medford, Oregon, Estados Unidos, 97504
        • Investigational Site Number 840012
      • Portland, Oregon, Estados Unidos, 97209
        • Investigational Site Number 840016
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Investigational Site Number 840040
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Investigational Site Number 840037
      • Upland, Pennsylvania, Estados Unidos, 19013
        • Investigational Site Number 840009
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29407
        • Investigational Site Number 840027
    • Texas
      • El Paso, Texas, Estados Unidos, 79902
        • Investigational Site Number 840030
      • San Antonio, Texas, Estados Unidos, 78229
        • Investigational Site Number 840050
    • Vermont
      • South Burlington, Vermont, Estados Unidos, 05403
        • Investigational Site Number 840052
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23229
        • Investigational Site Number 840049
    • Washington
      • Seattle, Washington, Estados Unidos, 98105
        • Investigational Site Number 840020
      • Tacoma, Washington, Estados Unidos, 98415-0299
        • Investigational Site Number 840019
    • Wisconsin
      • Madison, Wisconsin, Estados Unidos, 53792
        • Investigational Site Number 840034

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion criteria:

Medical diagnosis of persistent asthma for at least 12 months whose:

  • airway inflammation likely to be eosinophilic,
  • asthma partially controlled or uncontrolled on ICS plus LABA therapy.
  • On a stable dose of either Fluticasone/Salmeterol, Budesonide/Formoterol, Mometasone/Formoterol combination therapy for at least 1 month prior to screening.
  • Signed an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

Exclusion criteria:

  • Less than 18 years or greater than 65 years of age.
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation.
  • Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests.
  • Beta-adrenergic receptor blockers required for any reason.
  • Current smoker or cessation of smoking within the 6 months prior to screening.
  • Previous smoking with a smoking history >10 cigarette pack/years.
  • Participation in another study within 6 months prior to screening if the study medication was an antibody or within 30 days prior to screening for all other study medications.
  • Known or suspected non-compliance, alcohol or drug abuse.
  • Inability to follow the procedures of the study (e.g, due to language problems, psychological disorders).
  • Concomitant severe diseases or diseases for which the use of ICS or LABA were contraindicated.
  • Known allergy to doxycycline or related compounds.
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, or unwillingness to use a highly effective method of contraception throughout the study in women of childbearing potential.
  • Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo (for Dupilumab)
Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Droga: Placebo (for Dupilumab)
Solution for injection, one subcutaneous injection.
Droga: Fluticasone/Salmeterol combination therapy
Oral inhalation twice daily.
Droga: Fluticasone monotherapy
Oral inhalation twice daily.
Droga: Albuterol
Oral inhalation as needed.
Droga: Levalbuterol
Oral inhalation as needed.
Experimental: Dupilumab 300 mg qw
Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
Droga: Fluticasone/Salmeterol combination therapy
Oral inhalation twice daily.
Droga: Fluticasone monotherapy
Oral inhalation twice daily.
Droga: Albuterol
Oral inhalation as needed.
Droga: Levalbuterol
Oral inhalation as needed.
Droga: Dupilumab
Solution for injection, one subcutaneous injection.
Otros nombres:
  • REGN668
  • SAR231893

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants With Asthma Exacerbation
Periodo de tiempo: Baseline up to Week 12
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or hospitalization. The occurrence of asthma exacerbations by individual criteria are reported.
Baseline up to Week 12

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to First Asthma Exacerbation: Kaplan-Meier Estimates at Week 4, Week 8 and Week 12
Periodo de tiempo: Baseline up to Week 12
The time-to-asthma exacerbation was defined as the time from the date of randomization to the date of the first asthma exacerbation event; for participants without asthma exacerbation, it was censored at the end of treatment visit date. The median time to first asthma exacerbation was not estimated because the number of asthma exacerbations was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of asthma exacerbation at Week 4, 8 and 12, are presented as the descriptive measure statistics.
Baseline up to Week 12
Percentage of Participants With Composite Asthma Events
Periodo de tiempo: Baseline up to Week 12
Composite asthma event was defined as a 30% or greater reduction from baseline in morning PEF on 2 consecutive days together with 6 or more additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days.
Baseline up to Week 12
Change From Baseline in Forced Expiratory Flow in One Second (FEV1) to Week 12
Periodo de tiempo: Baseline, Week 12
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Baseline, Week 12
Change From Baseline in Peak Expiratory Flow (PEF) to Week 12
Periodo de tiempo: Baseline, Week 12
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Baseline, Week 12
Change From Baseline in Asthma Control Questionnaire (5-question Version [ACQ-5]) to Week 12
Periodo de tiempo: Baseline, Week 12
ACQ-5 questionnaire is a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score is the mean of the 5 questions and range between 0 (disease totally controlled) and 6 (disease severely uncontrolled), a higher score indicated lower asthma control.
Baseline, Week 12
Change From Baseline in 22-item Sinonasal Outcome Test (SNOT-22) Score to Week 12
Periodo de tiempo: Baseline, Week 12
The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Baseline, Week 12
Change From Baseline in Morning Asthma Symptom Scores to Week 12
Periodo de tiempo: Baseline, Week 12
AM (ante meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the night. It ranges from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning. No nighttime awakenings,2= Woke up once because of asthma (including early awakening),3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Baseline, Week 12
Change From Baseline in Evening Asthma Symptom Scores to Week 12
Periodo de tiempo: Baseline, Week 12
PM (post meridiem) symptom scoring system rates were participant's overall asthma symptoms experienced during the day. It ranges from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Baseline, Week 12
Change From Baseline in Number of Nocturnal Awakenings Per Day to Week 12
Periodo de tiempo: Baseline, Week 12
Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Baseline, Week 12
Change From Baseline in Number of Inhalations Per Day of Albuterol or Levalbuterol to Week 12
Periodo de tiempo: Baseline, Week 12
Number of Albuterol or Levalbuterol inhalations were recorded daily by the participants in their electronic diary as Albuterol or Levalbuterol was to be used only as needed for symptoms, not on a regular basis or prophylactically.
Baseline, Week 12

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Sanofi

Colaboradores

Regeneron Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2011

Finalización primaria (Actual)

1 de octubre de 2012

Finalización del estudio (Actual)

1 de octubre de 2012

Fechas de registro del estudio

Enviado por primera vez

9 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

9 de marzo de 2011

Publicado por primera vez (Estimar)

11 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de junio de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

7 de junio de 2017

Última verificación

1 de junio de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACT11457
  • U1111-1117-7826 (Otro identificador: UTN)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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