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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

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • dupilumab

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

754 Participants
are divided into 2 treatment groups
Group A: dupilumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first all-cause event

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

Time frame
Through day 90
2

Number of moderate or severe COPD exacerbations

Time frame
Through day 90

Secondary outcomes

1

Time to first COPD-related event

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

Time frame
Through day 90
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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Sanofi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: