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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394063
• Other study ID #: Ttrial
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: Ting Li
• Phone: +8613916927066
• Email: leeting007[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Telitacicept
Telitacicept 160 mg SC every other week

Drug:
• Placebo
Placebo to Telitacicept

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis	Subgroup analysis aiming to investigate which population will benefit most from telitacicept with prespecified factors	52 weeks
Primary	Percentage of patients with disease flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Percentage of patients with mild/moderate flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Percentage of patients with major flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Time to first disease flare	Time to first disease flare defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Secondary	Prednisone dose at each visit	Compare the prednisone dose at each visit	52 weeks
Secondary	PGA score at each visit	Compare the disease activity measured by PGA score at each visit	52 weeks
Secondary	SELENA-SLEDAI score at each visit	Compare the disease activity measured by SELENA-SLEDAI score at each visit	52 weeks
Secondary	Maintenance time of LLDAS/Remission	To record the maintenance time of LLDAS/Remission	52 weeks
Secondary	Number of participants with adverse events as assessed by CTCAE v5.0	The safety of telitacicept	52 weeks