Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456567
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus REMESLE-2
Sponsor:
RemeGen Co Ltd
Organization:
RemeGen Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus REMESLE-2
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active 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 diminished health-related quality of life HRQoL persistent disease activity disease flares intolerance to standard of care SOC therapies and development of organ damage and co-morbidities
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator BLyS and a proliferating-inducing ligand APRIL Blocking the interaction of BLyS and APRIL with their cell membrane receptors TACI B-cell maturation antigen BCMA and B-cell activating factor receptor BAFF-R would inhibit B cell proliferation and maturation suppresses immune responses and may alleviate autoimmune symptoms
This is a multicenter randomized double-blind placebo-controlled phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care SoC therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE
Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator BLyS and a proliferating-inducing ligand APRIL Blocking the interaction of BLyS and APRIL with their cell membrane receptors TACI B-cell maturation antigen BCMA and B-cell activating factor receptor BAFF-R would inhibit B cell proliferation and maturation suppresses immune responses and may alleviate autoimmune symptoms
This is a multicenter randomized double-blind placebo-controlled phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care SoC therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE
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