Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196203
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-12-24
Brief Title:
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Sponsor:
Akeso
Organization:
Akeso
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Phase 2 Study of AK117Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes
Status:
RECRUITING
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:
None
Brief Summary:
This is a Phase 2 randomized double-blind placebo-controlled multicenter study evaluating the efficacy and safety of AK117 or placebo combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes HR-MDS
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