Vunakizumab for mild to moderate lupus

Pilot Study on the Treatment of Vunakizumab in Mild to Moderate Systemic Lupus Erythematosus

This trial will test whether the antibody vunakizumab helps adults with mild to moderate lupus reduce skin and joint symptoms.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Chinese SLE Treatment And Research Group (Academic / other)
• Drugs / interventions: Vunakizumab, funakizumab, belimumab, methotrexate, cyclophosphamide, Prednisone, Ustekinumab, secukinumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06881290 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–65 meeting 2019 EULAR/ACR SLE criteria with SLEDAI 2–12, mucocutaneous or joint involvement, BMI 18–35, on stable low‑dose prednisone (≤20 mg/day) and at most one immunosuppressant are the intended participants.

Not a fit: Patients with major organ dysfunction (severe nephritis, central nervous system lupus, or other significant organ damage) or very high overall disease activity are unlikely to benefit from this early phase trial.

Why it matters

Potential benefit: If successful, vunakizumab could reduce skin and joint inflammation in SLE and may allow lower steroid doses.

How similar studies have performed: There is indirect support from ustekinumab (IL‑12/23) showing benefit in SLE and case reports of secukinumab helping cutaneous overlap cases, but no large clinical trials have directly tested IL‑17 blockers in SLE so far.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)

Conditions Lupus Erythematosus, Systemic; Vunakizumab; Systemic lupus erythematosus