Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT06375005
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Cutaneous Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Mar 2024
Primary completion
Jan 6, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mycophenolate Mofetil + Telitacicept
    All patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks.
  • Active Comparator: Mycophenolate Mofetil
    Participants will be treated with MMF 0.5g twice a day for 48 weeks.

Primary Outcome Measure

Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 [ Time Frame: Baseline, Week 48 ]

Central Contacts

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