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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Placebo; Biological: Telitacicept

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 Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Li; Phone Number: +8613916927066; Email: leeting007@163.com
• Study Contact Backup: Name: Shuang Ye; Email: ye_shuang2000@163.com

Study Locations

• China
  • Shanghai, China, 201112
    • Recruiting
    • Ren Ji Hospital
    • Contact: Ting Li, Dr; Phone Number: +8613916927066

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept; Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.	Biological: Telitacicept; Telitacicept 160 mg SC every other week
Placebo Comparator: Placebo; Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.	Drug: Placebo; Placebo to Telitacicept

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with mild/moderate flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Percentage of patients with major flares	Disease flare is defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Time to first disease flare	Time to first disease flare defined by modified SELENA-SLEDAI SLE flare index (SFI).	52 weeks
Prednisone dose at each visit	Compare the prednisone dose at each visit	52 weeks
PGA score at each visit	Compare the disease activity measured by PGA score at each visit	52 weeks
SELENA-SLEDAI score at each visit	Compare the disease activity measured by SELENA-SLEDAI score at each visit	52 weeks
Maintenance time of LLDAS/Remission	To record the maintenance time of LLDAS/Remission	52 weeks
Number of participants with adverse events as assessed by CTCAE v5.0	The safety of telitacicept	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup analysis	Subgroup analysis aiming to investigate which population will benefit most from telitacicept with prespecified factors	52 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Ttrial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No