NCT06394063Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 28 Apr 2024
- Start date
- 28 Jun 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT06394063
What you commit to
- Study type: Interventional
- Planned participants: 176
- From 28 Jun 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Exposure to cyclophosphamide within past 6 months before screening;
- Exposure to any B cell targeted therapy (Rituximab/Belimumab/Telitacicept) within past 6 months before screening;
Other illness
- 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;
- Active hepatitis or a history of severe liver disease;
- Current infections (HIV/tuberculosis/COVID-19, etc.) at screening;
Lab values
- Hepatic or renal dysfunction: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; GFR \< 60ml/min;
Other
- Pregnant women, lactating women;
- A significant decrease in immunoglobulin level, IgG\<5g/L;
- Not suitable for the study in the opinion of the investigator.
Who the study is looking for
- Age 18-70 years;
- 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;
- 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;
- Sign the informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ren Ji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.