Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546540
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluator Blind Controlled Preliminary Clinical Study of Telitacicept in the Treatment of Diffuse Systemic Sclerosis With Progressive Skin Progression
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Systemic sclerosis SSc is a chronic multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities and may involve the musculoskeletal gastrointestinal pulmonary cardiac renal neuromuscular and urogenital systems At present there is no clear and effective drug treatment for the progression of scleroderma skin lesions and there is a lack of authoritative treatment recommendations In recent years research on the treatment of B cells in SSc suggests that targeted B cell therapy has certain safety and effectiveness for SSc patients Telitacicept is a fully human fusion protein that is a fusion of TACI protein and IgG1 protein Telitacicept can inhibit the further development and maturation of immature B cells by blocking BLyS At the same time Telitacicept can also inhibit the differentiation of mature B cells into plasma cells by blocking APRIL and affect the secretion of abnormal self reactive plasma cell autoantibodies better controlling disease activity The effectiveness and safety of SSc treatment require further research This study is an evaluator blind parallel controlled clinical trial that included 20 SSc patients who still had skin progression despite conventional treatment The patients were divided into two groups one group included patients who did not improve with conventional treatment for skin lesions and the other group included patients who received traditional conventional treatment The main outcome of the study was to evaluate the efficacy and safety of Telitacicept in the treatment of progressive skin lesions in SSc and the secondary outcome was to evaluate the impact of Telitacicept on lung function gastrointestinal symptoms pulmonary arterial hypertension disease activity and quality of life in SSc
Detailed Description:
None
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