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
- Phase
- N/A
- Intervention
- Telitacicept
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- RenJi Hospital
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Percentage of patients with disease flares
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
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.
Arms & Interventions
Telitacicept
Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.
Intervention: Telitacicept
Placebo
Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of patients with disease flares
Time Frame: 52 weeks
Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).
Secondary Outcomes
- Percentage of patients with mild/moderate flares(52 weeks)
- Percentage of patients with major flares(52 weeks)
- Prednisone dose at each visit(52 weeks)
- PGA score at each visit(52 weeks)
- SELENA-SLEDAI score at each visit(52 weeks)
- Maintenance time of LLDAS/Remission(52 weeks)
- Time to first disease flare(52 weeks)
- Number of participants with adverse events as assessed by CTCAE v5.0(52 weeks)