Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531395
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögrens Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants with Sjögrens Disease
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögrens Disease
Detailed Description:
This is a 56-week 24-week randomized double-blind period 24-week active treatment period and 8-week safety follow-up period multicenter randomized double-blind placebo-controlled dose-ranging study to evaluate the efficacy and safety of abiprubart in participants with Sjögrens Disease with moderate or high systemic disease activity according to the European League Against Rheumatism EULAR Sjögrens Syndrome Disease Activity Index ESSDAI The objectives of the study are to evaluate efficacy safety pharmacokinetics PK and pharmacodynamics PD of abiprubart compared with placebo across the estimated therapeutic range using different dosing regimens of abiprubart
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