Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT06881290

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Led by Chinese SLE Treatment And Research Group · Updated on 2025-07-10

20

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 its pathogenesis involves complex cytokine dysregulation, emerging evidence implicates IL-17 as a potential contributor. Elevated serum IL-17 levels have been observed in SLE patients compared to healthy controls, with heightened expression detected in renal and cutaneous lesions. Ustekinumab, a monoclonal antibody targeting IL-23/IL-12 that indirectly modulates IL-17 signaling, demonstrated superior efficacy and safety to placebo in an SLE clinical trial, particularly in glucocorticoid dose reduction. Notably, no clinical trials have directly evaluated IL-17-targeted therapies for SLE, though case reports suggest secukinumab (an anti-IL-17A agent) may improve cutaneous manifestations in psoriasis-SLE overlap patients. Vunakizumab, a humanized anti-IL-17A monoclonal antibody (IgG1/κ) with a unique epitope-binding profile, selectively inhibits IL-17A-mediated inflammatory signaling. Its established safety profile and infrequent dosing regimen in IL-17-mediated diseases (e.g., psoriasis, psoriatic arthritis) warrant investigation in SLE. The investigators aim to provide new treatment options for SLE patients

CONDITIONS

Official Title

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 to 65 years with a diagnosis of SLE according to 2019 classification criteria
  • SLE disease activity index (SLEDAI) score between 2 and 12 with clinical activity
  • New or recurring skin or joint symptoms
  • Stable treatment with prednisone or equivalent corticosteroids at 20 mg/day or less for over 4 weeks
  • Use of no more than one immunosuppressant type for more than 12 weeks (allowed drugs include methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine)
  • Allowed use of antimalarial medications
  • Body mass index between 18 and 35 kg/m² at screening
  • Medically suitable for Vunakizumab combined with corticosteroids
  • Willingness to provide written informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Major organ dysfunction such as encephalopathy, renal insufficiency, severe heart failure (NYHA class III-IV), pulmonary hypertension, or interstitial lung disease
  • Active severe SLE organ involvement including lupus cerebritis, active lupus nephritis with proteinuria ≥1g/24h, myocardial involvement, gastrointestinal vasculitis, diffuse alveolar hemorrhage, thrombocytopenic purpura, hemophagocytic syndrome, or retinopathy
  • Presence of other autoimmune diseases that may affect study results (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
  • Liver dysfunction with ALT/AST levels greater than 1.5 times the upper limit of normal or total bilirubin above normal
  • History of cancer or active malignancy within the last 5 years
  • Other conditions requiring corticosteroid treatment such as asthma or Crohn's disease
  • Active infections requiring treatment including tuberculosis, hepatitis B or C, HIV, or CMV
  • Major surgery in the 3 months before screening
  • Known allergy or intolerance to Vunakizumab
  • Pregnancy, breastfeeding, or plans to become pregnant
  • Use of biologic therapies within 3 months prior to the study
  • Recent intensive therapies such as high-dose corticosteroids, plasmapheresis, intravenous immunoglobulin, or cyclophosphamide within 3 months
  • Any condition judged by the investigators to interfere with study completion or patient safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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