Ignite Creation Date:
2024-07-17 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473779
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-10
Brief Title:
Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicentre Randomised Open-Label Parallel-Group Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients With Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ARRIVAL
Brief Summary:
The objective of this study is to assess the potential for tezepelumab-treated patients subcutaneous administration to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma
Study details include
1 The study duration will be up to 72 weeks
2 The treatment duration will be up to 68 weeks
3 The visit frequency will be once every 4 weeks Q4W
Study details include
1 The study duration will be up to 72 weeks
2 The treatment duration will be up to 68 weeks
3 The visit frequency will be once every 4 weeks Q4W
Detailed Description:
This is a multicentre randomised open-label parallel-group phase IIIb study to assess the potential for tezepelumab-treated patients to 1 reduce maintenance therapy without the loss of asthma control at Week 56 among those who demonstrated asthma control or low biomarkers at Week 24 and 2 be in asthma control and have characteristics of clinical remission at Week 24
Approximately 65 sites in 10 countries will enrol adult and adolescent patients with severe uncontrolled asthma
The study is divided into 5 phases as described below
ScreeningRun-in Phase from Week -4 until Week 0 up to 4 Weeks
Treatment Induction Phase Week 0 to Week 4
Treatment Continuation Phase Week 4 to Week 24
Tezepelumab Treatment With or Without ICS Step-down Therapy Phase Week 24 to Week 56
Maintenance Phase Week 56 to Week 72
Approximately 65 sites in 10 countries will enrol adult and adolescent patients with severe uncontrolled asthma
The study is divided into 5 phases as described below
ScreeningRun-in Phase from Week -4 until Week 0 up to 4 Weeks
Treatment Induction Phase Week 0 to Week 4
Treatment Continuation Phase Week 4 to Week 24
Tezepelumab Treatment With or Without ICS Step-down Therapy Phase Week 24 to Week 56
Maintenance Phase Week 56 to Week 72
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None