Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388889
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-29
First Post:
2024-03-27
Brief Title:
Phase III Long-Term Extension Study With Dexpramipexole
Sponsor:
Areteia Therapeutics
Organization:
Areteia Therapeutics
Study Overview
Official Title:
An Open-Label Long-Term Phase III Extension Study to Assess the Long-Term Safety and Tolerability of Dexpramipexole in Participants With Severe Eosinophilic Asthma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
EXHALE-5
Brief Summary:
The goal of this clinical trial is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma aged 12 years on Global Initiative for Asthma GINA 2021 GINA 2021 Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3
Detailed Description:
None
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