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 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
754
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Clinical Trials Administrator
- Numéro de téléphone: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
|
Administré selon le protocole
|
|
Expérimental: dupilumab
|
Administré par le protocole
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to first all-cause event
Délai: 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
Délai: Through day 90
|
Through day 90
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to first COPD-related event
Délai: 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
Délai: Through day 90
|
Through day 90
|
|
|
Number of all-cause non-elective hospital readmissions
Délai: Through day 90
|
Through day 90
|
|
|
Number of ED visits
Délai: Through day 90
|
Through day 90
|
|
|
Number of COPD-related hospital readmissions
Délai: Through day 90
|
Through day 90
|
|
|
Number of COPD-related ED visits
Délai: Through day 90
|
Through day 90
|
|
|
Number of all-cause deaths
Délai: Through day 90
|
Through day 90
|
|
|
Number of COPD-related deaths
Délai: Through day 90
|
Through day 90
|
|
|
Occurrence of all-cause non-elective hospital readmissions
Délai: Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause ED visits
Délai: Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause deaths
Délai: Through day 60
|
Through day 60
|
|
|
Occurrence of COPD-related hospital readmissions
Délai: Through day 60
|
Through day 60
|
|
|
Occurrence of ED visits
Délai: Through day 60
|
Through day 60
|
|
|
Occurrence of deaths
Délai: Through day 60
|
Through day 60
|
|
|
Change in Chronic Airways Assessment Test (CAAT) score
Délai: 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
Délai: 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)
Délai: Through day 90
|
Through day 90
|
|
|
Occurrence of Serious Adverse Events (SAEs)
Délai: Through day 90
|
Through day 90
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Clinical Trial Management, Regeneron Pharmaceuticals
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 juin 2026
Achèvement primaire (Estimé)
30 juillet 2028
Achèvement de l'étude (Estimé)
30 juillet 2028
Dates d'inscription aux études
Première soumission
8 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R668-COPD-2491
- 2025-524392-23-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Délai de partage 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
Critères d'accès au partage 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
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .