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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: dupilumab

• Study Type: Interventional
• Enrollment (Estimated): 754
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
2. 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
3. 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:

1. Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
2. Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
3. Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
4. Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
5. Cardiac-related comorbidity, as defined in the protocol
6. Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
7. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered per the protocol
Experimental: dupilumab	Drug: dupilumab; Administered per the protocol; Other Names: REGN668; SAR231893; Dupixent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first all-cause event	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		Through day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first COPD-related event	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		Through day 90
Number of all-cause non-elective hospital readmissions		Through day 90
Number of ED visits		Through day 90
Number of COPD-related hospital readmissions		Through day 90
Number of COPD-related ED visits		Through day 90
Number of all-cause deaths		Through day 90
Number of COPD-related deaths		Through day 90
Occurrence of all-cause non-elective hospital readmissions		Through day 60
Occurrence of all-cause ED visits		Through day 60
Occurrence of all-cause deaths		Through day 60
Occurrence of COPD-related hospital readmissions		Through day 60
Occurrence of ED visits		Through day 60
Occurrence of deaths		Through day 60
Change in Chronic Airways Assessment Test (CAAT) score	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	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)		Through day 90
Occurrence of Serious Adverse Events (SAEs)		Through day 90

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: dupilumab; Eosinophilic phenotype; Type 2 inflammation; Moderate and/or Severe Exacerbation; Elevated blood eosinophil counts
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; dupilumab
• Other Study ID Numbers: R668-COPD-2491; 2025-524392-23-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

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

• IPD Sharing Access Criteria: 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No