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OpenTrials
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NCT Number: NCT07587658

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab

Drug

Administered per the protocol

Other names: Dupixent®, REGN668, SAR231893

Placebo

Drug

Administered per the protocol

Primary outcomes

  1. Time to first all-cause event

    Time frame: Through day 90

    All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death

  2. Number of moderate or severe COPD exacerbations

    Time frame: Through day 90

Secondary outcomes

  1. Time to first COPD-related event

    Time frame: Through day 90

    COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death

  2. Time to first moderate and/or severe COPD exacerbation

    Time frame: Through day 90

  3. Number of all-cause non-elective hospital readmissions

    Time frame: Through day 90

  4. Number of ED visits

    Time frame: Through day 90

  5. Number of COPD-related hospital readmissions

    Time frame: Through day 90

  6. Number of COPD-related ED visits

    Time frame: Through day 90

  7. Number of all-cause deaths

    Time frame: Through day 90

  8. Number of COPD-related deaths

    Time frame: Through day 90

  9. Occurrence of all-cause non-elective hospital readmissions

    Time frame: Through day 60

  10. Occurrence of all-cause ED visits

    Time frame: Through day 60

  11. Occurrence of all-cause deaths

    Time frame: Through day 60

  12. Occurrence of COPD-related hospital readmissions

    Time frame: Through day 60

  13. Occurrence of ED visits

    Time frame: Through day 60

  14. Occurrence of deaths

    Time frame: Through day 60

  15. Change in Chronic Airways Assessment Test (CAAT) score

    Time frame: 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.

  16. Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score

    Time frame: 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.

  17. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Through day 90

  18. Occurrence of Serious Adverse Events (SAEs)

    Time frame: Through day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: MISSION

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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