Vunakizumab for mild to moderate lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial of vunakizumab, a humanized anti‑IL‑17A monoclonal antibody, in adults (18–65) with mild to moderate systemic lupus erythematosus who have new or recurrent mucocutaneous or joint involvement. Eligible participants must have SLEDAI scores of 2–12, be on a stable background regimen (including prednisone ≤20 mg/day and at most one immunosuppressant), and meet BMI and consent requirements. The study is conducted at Peking Union Medical College Hospital and focuses on initial safety, tolerability, pharmacology, and early signs of clinical activity of IL‑17A blockade in SLE. Treatment is given in combination with permitted corticosteroids per investigator assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18-65 years meeting the 2019 EULAR/ACR classification criteria for SLE.
2. SLEDAI score was within 2-12 scores (with clinical SLEDAI \[cSLEDAI\] ≠ 0).
3. Occurence of new or recurrent mucocutaneous or joint involvement.
4. 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.
5. Body mass index (BMI) 18-35 kg/m² at screening.
6. Clinically eligible for Vunakizumab combination therapy with corticosteroids after investigator assessment.
7. Willing to provide written informed consent with demonstrated compliance.

Exclusion Criteria:

1. SLE with major organ dysfunction including Encephalopathy/cognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension/interstitial lung disease
2. 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
3. Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
4. Liver dysfunction: ALT/AST \>1.5×ULN or total bilirubin \>1×ULN.
5. Active malignancy within 5 years or history of malignancy.
6. Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).
7. Active infections requiring treatment:Tuberculosis, HBV/HCV/HIV/CMV infections
8. Major surgery within 3 months prior to screening.
9. Hypersensitivity or intolerance to funakizumab.
10. Pregnancy, lactation, or planned pregnancy.
11. Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).
12. Recent intensive therapies: Systemic corticosteroids within 3 months/ Plasmapheresis/IVIG/cyclophosphamide within 3 months
13. Any condition deemed by investigators to compromise study completion or patient safety.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.