Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02853084
Status:
TERMINATED
Last Update Posted:
2017-01-04
First Post:
2016-05-10
Brief Title:
HL2351 CAPS Phase II Study
Sponsor:
Handok Inc
Organization:
Handok Inc
Study Overview
Official Title:
An Open Label Single Arm Trial to Evaluate the Efficacy Safety and Pharmacokinetics of HL2351 in Patients With Cryopyrin Associated Periodic Syndromes
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
difficult of recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label single arm trial to evaluate the efficacy safety and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes CAPS
Detailed Description:
This trial enrolls patients with CAPS being on stable dose of anakinra daily and then switch over HL2351 given once weekly It consists of 4 phases 6-week screening single dose PK 6-month multiple dose and 18-month extension phase
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