Chronic Obstructive Pulmonary Disease (COPD)Phase 4MISSIONNCT07587658
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
A Phase 4 study testing dupilumab in people with Chronic Obstructive Pulmonary Disease (COPD), run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- dupilumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2026to 30 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, 08062
About this study
Official 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
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
- Being tested
- dupilumab, Placebo
- Keywords
- Moderate and/or Severe Exacerbation, Eosinophilic phenotype, Elevated blood eosinophil counts, Type 2 inflammation, dupilumab
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dupilumabDrug
Also called Dupixent®, REGN668, SAR231893
Administered per the protocol
PlaceboDrug
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| dupilumab | Experimental | Not described Receives: Drug: dupilumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first all-cause event
All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
Measured: Through day 90
Number of moderate or severe COPD exacerbations
Measured: Through day 90
Secondary outcomes (18)
Time to first COPD-related event
COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
Measured: Through day 90
Time to first moderate and/or severe COPD exacerbation
Measured: Through day 90
Number of all-cause non-elective hospital readmissions
Measured: Through day 90
Number of ED visits
Measured: Through day 90
Number of COPD-related hospital readmissions
Measured: Through day 90
Number of COPD-related ED visits
Measured: Through day 90
Number of all-cause deaths
Measured: Through day 90
Number of COPD-related deaths
Measured: Through day 90
Occurrence of all-cause non-elective hospital readmissions
Measured: Through day 60
Occurrence of all-cause ED visits
Measured: Through day 60
Occurrence of all-cause deaths
Measured: Through day 60
Occurrence of COPD-related hospital readmissions
Measured: Through day 60
Occurrence of ED visits
Measured: Through day 60
Occurrence of deaths
Measured: 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.
Measured: 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.
Measured: From baseline through day 90
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Through day 90
Occurrence of Serious Adverse Events (SAEs)
Measured: Through day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start6 Oct 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 754 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587658
- Sponsor's protocol ID
- R668-COPD-2491
- Other IDs
- 2025-524392-23-00, 2025
- Acronym
- MISSION
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07587658
- Acronym / sponsor ID
- MISSION / R668-COPD-2491
- Keywords
- Moderate and/or Severe Exacerbation, Eosinophilic phenotype, Elevated blood eosinophil counts, Type 2 inflammation, dupilumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 754 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dupilumab | Experimental | Drug: dupilumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dupilumabAlso: Dupixent®, REGN668, SAR231893Administered per the protocol | Drug | dupilumab |
| PlaceboAdministered per the protocol | Drug | Placebo |
Primary outcome
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
Number of moderate or severe COPD exacerbations
Time frame: Through day 90
18 secondary outcomes
Time to first COPD-related event
Time frame: Through day 90
Time to first moderate and/or severe COPD exacerbation
Time frame: Through day 90
Number of all-cause non-elective hospital readmissions
Time frame: Through day 90
Number of ED visits
Time frame: Through day 90
Number of COPD-related hospital readmissions
Time frame: Through day 90
Number of COPD-related ED visits
Time frame: Through day 90
Number of all-cause deaths
Time frame: Through day 90
Number of COPD-related deaths
Time frame: Through day 90
Occurrence of all-cause non-elective hospital readmissions
Time frame: Through day 60
Occurrence of all-cause ED visits
Time frame: Through day 60
Occurrence of all-cause deaths
Time frame: Through day 60
Occurrence of COPD-related hospital readmissions
Time frame: Through day 60
Occurrence of ED visits
Time frame: Through day 60
Occurrence of deaths
Time frame: Through day 60
Change in Chronic Airways Assessment Test (CAAT) score
Time frame: From baseline through day 90
Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score
Time frame: From baseline through day 90
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Through day 90
Occurrence of Serious Adverse Events (SAEs)
Time frame: Through day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 3
Study of Fluticasone/Formoterol/Glycopyrronium for the Treatment Chronic Obstructive Pulmonary Disease (TRIPLAR)
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dupilumab in people with Chronic Obstructive Pulmonary Disease (COPD), run by Regeneron Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first all-cause event (time frame: Through day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.