Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577116
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Open-Label Extension Study for Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Extension Study Evaluating the Safety Tolerability PK Immunogenicity and Clinical Response of Multiple Doses of IV AK006 in Subjects With H1 Antihistamine Refractory Chronic Spontaneous Urticaria Completing Study AK006-001
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
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:
None
Brief Summary:
An open label extension OLE study offered to subjects with Chronic Spontaneous Urticaria that have completed the AK006-001 NCT06072157 Part C referred to as the Main study portion of the study Qualified subjects will receive up to four doses of the study drug AK006 through an intravenous infusion every 4 weeks There is a 16-week follow up period once all the scheduled infusions have been completed Subjects will be follow for evaluation of safety tolerability PK immunogenicity and clinical response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None