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Recruiting NCT06394063

Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients

No phase Interventional Systemic Lupus Erythematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telitacicept, Placebo.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized, Double-blind, Placebo-controlled Trial of Efficacy and Safety of Low-dose Telitacicept for Prevention of Flares in SLE Patients With Low Disease Activity

Overview

This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Detailed description

Background: There are still two major problems in the treatment of SLE: flare and long-term organ damage. BLISS-52 showed there was some reduction of flare (80% vs 71%) in belimumab , but the difference was not significant. Another study tested the efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe SLE in which analysis of atacicept 150 mg suggested benefit.

Telitacicept , a BAFF/APRIL dual-target-inhibitor, which has been proved to be effective in treatment of SLE. But there is no study to show its effectiveness for prevention of flares in SLE patients with low disease activity. In this study, we take telitacicept as maintain treatment in stable SLE patients to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Interventions

  • Biological Telitacicept
    Telitacicept 160 mg SC every other week
  • Drug Placebo
    Placebo to Telitacicept

Primary outcome measures

  • Percentage of patients with disease flares [Time frame: 52 weeks]
Secondary outcome measures (8)
  • Percentage of patients with mild/moderate flares [Time frame: 52 weeks]
  • Percentage of patients with major flares [Time frame: 52 weeks]
  • Time to first disease flare [Time frame: 52 weeks]
  • Prednisone dose at each visit [Time frame: 52 weeks]
  • PGA score at each visit [Time frame: 52 weeks]
  • SELENA-SLEDAI score at each visit [Time frame: 52 weeks]
  • Maintenance time of LLDAS/Remission [Time frame: 52 weeks]
  • Number of participants with adverse events as assessed by CTCAE v5.0 [Time frame: 52 weeks]

Eligibility criteria

Inclusion criteria

  • Age 18-70 years;
  • SLE patients with low disease activity (SELENA-SLEDAI score< 8 at screening ); disease duration more than 3 months；no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
  • A stable treatment regimen with fixed doses of prednisone (≤ 30mg/day), antimalarial, or immunosuppressive drugs (mycophenolate mofetil/azathioprine/ciclosporin /tacrolimus/methotrexate/leflunomide) for at least 3 months;
  • Sign the informed consent.

Exclusion criteria

  • Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; GFR < 60ml/min;
  • Exposure to cyclophosphamide within past 6 months before screening;
  • Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
  • Pregnant women, lactating women;
  • History of Malignancy within the last 5 years, excluding adequately treated skin tumors (basal cell or squamous cell carcinoma) or carcinoma in situ of cervix;
  • Active hepatitis or a history of severe liver disease;
  • Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
  • A significant decrease in immunoglobulin level, IgG<5g/L;
  • Not suitable for the study in the opinion of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Ren Ji Hospital — Shanghai

Identifiers

NCT: NCT06394063 · Ttrial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗