Systemic Lupus Erythematosus
Conditions
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.
Interventions
BIOLOGICALTelitacicept
Telitacicept 160 mg SC every other week
DRUGPlacebo
Placebo to Telitacicept
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-70 years; 2. 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; 3. 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; 4. Sign the informed consent.
Exclusion criteria
1. Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min; 2. Exposure to cyclophosphamide within past 6 months before screening; 3. Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening; 4. Pregnant women, lactating women; 5. 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; 6. Active hepatitis or a history of severe liver disease; 7. Current infections (HIV/tuberculosis/COVID-19, etc.) at screening; 8. A significant decrease in immunoglobulin level, IgG\<5g/L; 9. Not suitable for the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with disease flares | 52 weeks | Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with mild/moderate flares | 52 weeks | Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI). |
| Percentage of patients with major flares | 52 weeks | Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI). |
| Time to first disease flare | 52 weeks | Time to first disease flare defined by modified SELENA-SLEDAI SLE flare index (SFI). |
| Prednisone dose at each visit | 52 weeks | Compare the prednisone dose at each visit |
| SELENA-SLEDAI score at each visit | 52 weeks | Compare the disease activity measured by SELENA-SLEDAI score at each visit |
| Maintenance time of LLDAS/Remission | 52 weeks | To record the maintenance time of LLDAS/Remission |
| Number of participants with adverse events as assessed by CTCAE v5.0 | 52 weeks | The safety of telitacicept |
| PGA score at each visit | 52 weeks | Compare the disease activity measured by PGA score at each visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis | 52 weeks | Subgroup analysis aiming to investigate which population will benefit most from telitacicept with prespecified factors |
Countries
China
Contacts
Primary ContactTing Li
Backup ContactShuang Ye
Outcome results
None listed