Pilot Study on the Treatment of Vunakizumab in Mild to Moderate Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the percentage of patients achieving an BICLA response at the end of 24 weeks
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Vunakizumab
干预措施: Vunakizumab (IL-17A inhibitor) (Drug)
结局指标
主要结局
the percentage of patients achieving an BICLA response at the end of 24 weeks
时间窗: From enrollment to the end of treatment at 24 weeks
The BICLA response was defined as a reduction of all severe (BILAG-2004 A) or moderately severe (BILAG-2004 B) disease activity at baseline to lower levels (BILAG-2004 B, C, or D and C or D, respectively) and no worsening in other organ systems (with worsening defined as ≥1 new BILAG-2004 A item or ≥2 new BILAG-2004 B items); no worsening in disease activity, as determined by the SLEDAI-2K score (no increase from baseline) and by the PGA score (no increase of ≥0.3 points from baseline)
次要结局
- the percentage of patients achieving an BICLA response at the end of 12 weeks(From enrollment to the end of treatment at 12 weeks)
- the percentage of patients achieving SRI-4 response at the end of 24 weeks.(From enrollment to the end of treatment at 24 weeks)
- the percentage of patients achieving SRI-4 response at the end of 12 weeks.(From enrollment to the end of treatment at 12 weeks)
- Changes from baseline in SLEDAI at 24 weeks(From enrollment to the end of treatment at 24 weeks)
- Changes from baseline in CLASI at 24 weeks.(From enrollment to the end of treatment at 24 weeks)
- Changes from baseline in PGA at 24 weeks(From enrollment to the end of treatment at 24 weeks)
- Changes from baseline of the SJC and TJC at 24 weeks(From enrollment to the end of treatment at 24 weeks)