Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312020
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-16
Brief Title:
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogrens Syndrome
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogrens syndrome SS
Detailed Description:
The study will enroll 2 SS populations Population 1 will include participants with moderate to high systemic disease activity Population 2 will include participants with moderate to severe subjective symptoms This study will include 3 periods screening 5 weeks treatment period 48 Weeks and follow-up period 12 weeks In the treatment period participants from each of the populations will be randomized to receive subcutaneous SC dose of HZN-1116 or placebo
Acquired from Horizon in 2024
Acquired from Horizon in 2024
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