This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization (MISSION)
8 de mayo de 2026 actualizado por: Regeneron Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy of Dupilumab Added on to Standard of Care (SOC) Treatment vs SOC Treatment Following Hospitalization for a COPD Exacerbation
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days).
The study is looking at another research question:
• What side effects may happen from taking the study drug
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
754
Fase
- Fase 4
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.
Estudio Contacto
- Nombre: Clinical Trials Administrator
- Número de teléfono: 844-734-6643
- Correo electrónico: clinicaltrials@regeneron.com
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Key Inclusion Criteria:
- Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
- Hospitalized or admitted to the ED >24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC
- Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital
Key Exclusion Criteria:
- Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
- Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
- Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
- Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
- Cardiac-related comorbidity, as defined in the protocol
- Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
- Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Administrado según el protocolo.
|
|
Experimental: dupilumab
|
Administrado por el protocolo
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to first all-cause event
Periodo de tiempo: Through day 90
|
All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
|
Through day 90
|
|
Number of moderate or severe COPD exacerbations
Periodo de tiempo: Through day 90
|
Through day 90
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to first COPD-related event
Periodo de tiempo: Through day 90
|
COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
|
Through day 90
|
|
Time to first moderate and/or severe COPD exacerbation
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of all-cause non-elective hospital readmissions
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of ED visits
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of COPD-related hospital readmissions
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of COPD-related ED visits
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of all-cause deaths
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Number of COPD-related deaths
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Occurrence of all-cause non-elective hospital readmissions
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause ED visits
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause deaths
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Occurrence of COPD-related hospital readmissions
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Occurrence of ED visits
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Occurrence of deaths
Periodo de tiempo: Through day 60
|
Through day 60
|
|
|
Change in Chronic Airways Assessment Test (CAAT) score
Periodo de tiempo: From baseline through day 90
|
CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease.
|
From baseline through day 90
|
|
Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score
Periodo de tiempo: From baseline through day 90
|
EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms.
|
From baseline through day 90
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Through day 90
|
Through day 90
|
|
|
Occurrence of Serious Adverse Events (SAEs)
Periodo de tiempo: Through day 90
|
Through day 90
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Clinical Trial Management, Regeneron Pharmaceuticals
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 (Estimado)
30 de junio de 2026
Finalización primaria (Estimado)
30 de julio de 2028
Finalización del estudio (Estimado)
30 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R668-COPD-2491
- 2025-524392-23-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Marco de tiempo para compartir IPD
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
Criterios de acceso compartido de IPD
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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