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

Not Applicable

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Biological: Telitacicept

• Registration Number: NCT06394063
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-28
• Study First Posted: 2024-05-01
• Study Start: 2024-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.
Telitacicept	Telitacicept	Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with disease flares	52 weeks	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).

Secondary Outcome Measures

Name	Time	Method
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).
Prednisone dose at each visit	52 weeks	Compare the prednisone dose at each visit
PGA score at each visit	52 weeks	Compare the disease activity measured by PGA score 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
Time to first disease flare	52 weeks	Time to first disease flare defined by modified SELENA-SLEDAI SLE flare index (SFI).
Number of participants with adverse events as assessed by CTCAE v5.0	52 weeks	The safety of telitacicept

Trial Locations

Locations (1)

Ren Ji Hospital; 🇨🇳 Shanghai, China