RecruitingPhase 4

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 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding dupilumab to usual COPD care helps prevent another flare-up over about 90 days. It is for adults hospitalized for a severe COPD flare-up. COPD is a long-term lung disease that makes breathing hard, and the study also checks for side effects.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a COPD diagnosis before being assigned to a study treatment group.
  • Be hospitalized or stay in the emergency room for more than 24 hours mainly because of a COPD flare-up.
  • Have the flare-up treated with steroid medicines and other usual care, which may include antibiotics.
  • Have high levels of eosinophils, a type of white blood cell, during the current flare-up, as defined by the study.

Who can't join

  • Have pneumonia as the main reason for admission, or develop it during the hospital stay.
  • Have had lung problems in the past 8 weeks that could make the treatment results hard to judge.
  • Have a serious lung disease other than COPD that could affect breathing and the treatment results.
  • Have a serious shortage of alpha-1 antitrypsin, a protein that protects the lungs, that could affect breathing and the treatment results.
  • Have a heart-related health condition covered by the study rules.
  • Have needed a breathing machine through a tube during the hospital stay for this flare-up.
  • Have received a biologic medicine, including an experimental one, for certain diseases involving inflammation within the past 6 months, or longer if the medicine stays in the body longer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NJ