NCT06881290RecruitingPhase 1
Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus
Pilot Study on the Treatment of Vunakizumab in Mild to Moderate Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 19 May 2025
- Primary completion date
- 20 Nov 2026
- Lead sponsor
- Chinese SLE Treatment And Research Group
- Diseases
- Lupus (SLE)
- NCT number
- NCT06881290
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 19 May 2025 to the primary completion date, 20 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).
- Major surgery within 3 months prior to screening.
- 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
Other illness
- 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
- 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
- Hypersensitivity or intolerance to funakizumab.
- Any condition deemed by investigators to compromise study completion or patient safety.
Lab values
- Liver dysfunction: ALT/AST \>1.5×ULN or total bilirubin \>1×ULN.
Other
- Pregnancy, lactation, or planned pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.