Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751487
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2021-02-08
Brief Title:
Study to Assess the Efficacy Safety and Tolerability of SAR440340REGN3500Itepekimab in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Parallel-group Phase 3 Study to Evaluate the Efficacy Safety and Tolerability of SAR440340 REGN3500 Itepekimab Anti-IL-33 mAb in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease COPD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
AERIFY-2
Brief Summary:
Primary Objective
Primary population former smokers cohort
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives
Primary population former smokers cohort
Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second FEV1 slope in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life HRQoL as assessed by St Georges Respiratory Questionnaire SGRQ in former smokers with moderate-to-severe COPD
Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
Evaluate the pharmacokinetic PK profile of itepekimab in former smokers with moderate-to-severe COPD
Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Secondary population current smokers cohort
Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Primary population former smokers cohort
Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD
Secondary Objectives
Primary population former smokers cohort
Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second FEV1 slope in former smokers with moderate-to-severe COPD
Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life HRQoL as assessed by St Georges Respiratory Questionnaire SGRQ in former smokers with moderate-to-severe COPD
Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
Evaluate the pharmacokinetic PK profile of itepekimab in former smokers with moderate-to-severe COPD
Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD
Secondary population current smokers cohort
Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Detailed Description:
The study duration per participant
Screening period is 3-5 weeks
Randomized investigational medicinal product IMP treatment period is 52 weeks for first cohort of randomized former smoker participants approximately 930 and cohort of current smokers approximately 280 and 24 to 52 weeks for potential additional randomized former smoker participants
Post-IMP treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note A long-term double-blinded extension study LTS18133 will be implemented to allow participants in this study to continue receiving active IMP for an additional period Only participants completing their End-of-Treatment EOT visit per this study protocol will be offered to participate in the LTS18133 study
Screening period is 3-5 weeks
Randomized investigational medicinal product IMP treatment period is 52 weeks for first cohort of randomized former smoker participants approximately 930 and cohort of current smokers approximately 280 and 24 to 52 weeks for potential additional randomized former smoker participants
Post-IMP treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note A long-term double-blinded extension study LTS18133 will be implemented to allow participants in this study to continue receiving active IMP for an additional period Only participants completing their End-of-Treatment EOT visit per this study protocol will be offered to participate in the LTS18133 study
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001819-24 | EUDRACT_NUMBER | CTIS | None |
| U1111-1250-2843 | REGISTRY | None | None |
| 2024-512012-21 | REGISTRY | None | None |