Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

January 6, 2027

Study Completion Date

December 31, 2027

Conditions
Diffuse Cutaneous Systemic Sclerosis
Interventions
DRUG

Telitacicept

Telitacicept is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.

DRUG

Mycophenolate Mofetil

All patients will receive background therapy with Mycophenolate Mofetil (MMF), administered orally at a dose of 0.5g twice daily for 48 weeks.

Trial Locations (9)

200433

RECRUITING

Huashan Hospital of Fudan University, Shanghai

225009

RECRUITING

Affiliated Hospital of Yangzhou University, Yangzhou

310006

RECRUITING

Hangzhou First People's Hospital, Hangzhou

310016

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine, Hangzhou

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

313100

RECRUITING

Changxing People's Hospital, Huzhou

314000

RECRUITING

The First Hospital of Jiaxing, Jiaxing

315000

RECRUITING

Ningbo First Hospital, Ningbo

325000

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER