Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04456673
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2020-06-30
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:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOTUS
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 or 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 antidrug 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 or 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 antidrug 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 |
|---|---|---|---|
| 2018-001954-91 | EUDRACT_NUMBER | ICTRP | None |
| U1111-1211-8837 | REGISTRY | None | None |