RecruitingPhase 2NCT06375005

Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis

The Efficacy and Safety of Telitacicept in the Treatment of Early Diffuse Cutaneous Systemic Sclerosis: a Multicenter, Open-label, Randomized Controlled Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

38 participants

Start Date

Jan 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This randomized, controlled clinical trial evaluates whether telitacicept — a biologic medication that targets two immune-signaling proteins (BAFF and APRIL) involved in inflammation and autoimmunity — can reduce skin thickening and slow disease progression in adults with early diffuse cutaneous systemic sclerosis (a form of scleroderma that causes progressive skin hardening and internal organ involvement). Mycophenolate mofetil (MMF), a standard immunosuppressive drug, will be used as background therapy in both groups. Adults aged 18–70 with a confirmed diagnosis of diffuse systemic sclerosis, disease duration of no more than 18 months from the first non-Raynaud symptom, and a modified Rodnan Skin Score of at least 10 may be eligible. Participation involves subcutaneous injections of telitacicept or standard care, regular clinic visits, and assessments of skin, lung, and overall disease status. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTelitacicept

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.

DRUGMycophenolate Mofetil

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


Locations(9)

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Changxing People's Hospital

Huzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06375005


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