Using telitacicept to prevent flares in lupus 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 testing if a new medication called telitacicept can help people with lupus stay stable and avoid flare-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | Rituximab, Belimumab, methotrexate, cyclophosphamide, prednisone |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06394063 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of low-dose telitacicept in preventing flares among patients with systemic lupus erythematosus (SLE) who have low disease activity. The study focuses on patients who have been stable on a fixed treatment regimen for at least three months and have a SELENA-SLEDAI score of less than 8. By administering telitacicept, a dual-target inhibitor, the trial seeks to determine if it can effectively maintain low disease activity and prevent flare-ups in SLE patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 with systemic lupus erythematosus exhibiting low disease activity.
Not a fit: Patients with hepatic or renal dysfunction, recent exposure to certain therapies, or a history of malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of disease flares in lupus patients, improving their quality of life.
How similar studies have performed: Previous studies have shown some success with similar approaches, but this specific use of telitacicept for low disease activity in SLE is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Ren Ji Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ting Li
- Email: leeting007@163.com
- Phone: +8613916927066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.