NCT06881290 Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus
| NCT ID | NCT06881290 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chinese SLE Treatment And Research Group |
| Condition | Lupus Erythematosus, Systemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2026-11-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-05-19 with a primary completion date of 2026-11-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Frequently Asked Questions
Who can join the NCT06881290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lupus Erythematosus, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06881290 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06881290 currently recruiting?
Yes, NCT06881290 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chinese SLE Treatment And Research Group to inquire about joining.
Where is the NCT06881290 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06881290 clinical trial?
NCT06881290 is sponsored by Chinese SLE Treatment And Research Group. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.