Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 3:59 AM
Study NCT ID:
NCT07185269
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE
Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Anti-BDCA2 Antibody SSGJ-626 in Subjects With Systemic Lupus Erythematosus
Status:
RECRUITING
Status Verified Date:
2025-09
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:
This study will evaluate the effect and safety of 626 in patients with SLE
Detailed Description:
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities.
The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.
The purpose of this study is to demonstrate the clinical efficacy and safety of 626 added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with SLE.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: