Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03930732
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2019-04-26
Brief Title:
Pivotal Study to Assess the Efficacy Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group 52-week Pivotal Study to Assess the Efficacy Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease COPD With Type 2 Inflammation
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOREAS
Brief Summary:
Primary Objective
To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease COPD as measured by
Annualized rate of acute moderate and severe COPD exacerbation AECOPD
Secondary Objectives
To evaluate the effect of dupilumab administered every 2 weeks on
Pre-bronchodilator forced expiratory volume in 1 second FEV1 over 12 weeks compared to placebo
Health related quality of life assessed by the change from baseline to Week 52 in the St Georges Respiratory Questionnaire SGRQ
Pre-bronchodilator FEV1 over 52 weeks compared to placebo
Lung function assessments
Moderate and severe COPD exacerbations
To evaluate safety and tolerability
To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies ADA
To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease COPD as measured by
Annualized rate of acute moderate and severe COPD exacerbation AECOPD
Secondary Objectives
To evaluate the effect of dupilumab administered every 2 weeks on
Pre-bronchodilator forced expiratory volume in 1 second FEV1 over 12 weeks compared to placebo
Health related quality of life assessed by the change from baseline to Week 52 in the St Georges Respiratory Questionnaire SGRQ
Pre-bronchodilator FEV1 over 52 weeks compared to placebo
Lung function assessments
Moderate and severe COPD exacerbations
To evaluate safety and tolerability
To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies ADA
Detailed Description:
Approximately 68 weeks including a 4-week screening period a 52-week treatment period and 12 weeks of follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001953-28 | EUDRACT_NUMBER | None | None |
| U1111-1211-8804 | OTHER | UTN | None |