Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524392-23-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dupilumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dupilumab | Drug | Administered per the protocol |
|
|
| 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 |
| 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 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
Not provided
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered per the protocol |
|
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided