Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT04968912
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2021-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05221619
Has Expanded Access, NCT# Status:
TEMPORARILY_NOT_AVAILABLE
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: