Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

Men or women aged 18-70 years old.

Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria.

dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria.

Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation).

Disqualifiers

Limited scleroderma.

Disease duration of greater than 3 years.

Rheumatic autoimmune disease other than SSc.

Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin.

Trial design

Treatments tested in this trial

  • Telitacicept
  • Mycophenolate Mofetil

Treatment groups

38 Participants
are divided into 2 treatment groups