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

NCT07587658 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: R668-COPD-24912025-524392-23-00
• Study Type: interventional
• Target: 754
• Locations: 0 countries
• Sites: N/A

Brief 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 duration (around 90 days). The study is looking at another research question: • What side effects may happen from taking the study drug

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Moderate and/or Severe Exacerbation; Eosinophilic phenotype; Elevated blood eosinophil counts; Type 2 inflammation; dupilumab

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Time to first COPD-related event

  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

Study Arms (2)

dupilumab

EXPERIMENTAL

Drug: dupilumab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

dupilumab DRUG

Administered per the protocol

Also known as: Dupixent®, REGN668, SAR231893

dupilumab

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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