Status:
RECRUITING
Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus
Lead Sponsor:
Chinese SLE Treatment And Research Group
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by heterogeneous clinical manifestations ranging from mild cutaneous involvement to severe multi-organ damage. While i...
Eligibility Criteria
Inclusion
- Patients aged 18-65 years meeting the 2019 EULAR/ACR classification criteria for SLE.
- SLEDAI score was within 2-12 scores (with clinical SLEDAI \[cSLEDAI\] ≠ 0).
- Occurence of new or recurrent mucocutaneous or joint involvement.
- Stable standard treatment regimen prior to study entry but not effect: Prednisone or equivalent corticosteroid dose ≤ 20 mg per day for more than 4 weeks; Immunosuppressant less than 1 type for more than 12 weeks, including methotrexate ≤15 mg per week, azathioprine ≤100mg per day, mycophenolate mofetil ≤1.5 g per day, tacrolimus ≤2 mg per day, cyclosporine ≤150 mg per day). Antimalarials was permitted.
- Body mass index (BMI) 18-35 kg/m² at screening.
- Clinically eligible for Vunakizumab combination therapy with corticosteroids after investigator assessment.
- Willing to provide written informed consent with demonstrated compliance.
Exclusion
- SLE with major organ dysfunction including Encephalopathy/cognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension/interstitial lung disease
- Active SLE-related organ involvement: Lupus cerebritis, Active lupus nephritis (proteinuria ≥1g/24h), Myocardial involvement, Gastrointestinal vasculitis, Diffuse alveolar hemorrhage, Thrombocytopenic purpura, Hemophagocytic syndrome, Retinopathy
- Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
- Liver dysfunction: ALT/AST \>1.5×ULN or total bilirubin \>1×ULN.
- Active malignancy within 5 years or history of malignancy.
- Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).
- Active infections requiring treatment:Tuberculosis, HBV/HCV/HIV/CMV infections
- Major surgery within 3 months prior to screening.
- Hypersensitivity or intolerance to funakizumab.
- Pregnancy, lactation, or planned pregnancy.
- Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).
- Recent intensive therapies: Systemic corticosteroids within 3 months/ Plasmapheresis/IVIG/cyclophosphamide within 3 months
- Any condition deemed by investigators to compromise study completion or patient safety.
Key Trial Info
Start Date :
May 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06881290
Start Date
May 19 2025
End Date
December 1 2027
Last Update
July 10 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730