Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 8:32 AM
Study NCT ID:
NCT03878303
Status:
UNKNOWN
Last Update Posted:
2019-03-18
First Post:
2019-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
Sponsor:
ACEA Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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 1b, double blind, randomized, placebo-controlled study of the safety and tolerability, pharmacokinetics and pharmacodynamics of AC0058TA in patients with systemic lupus erythematosus (SLE).
Detailed Description:
The study will be performed in adult patients with autoantibody (ANA) positive SLE, as defined by the American College of Rheumatology (ACR) 1997 criteria or System Lupus International Collaborating Clinic (SLICC) 2009 criteria who are receiving standard of care therapy for SLE.
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?: