Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

NCT06881290 | Recruiting Phase 1

• 1 other identifier: CSTAR011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Erythematosus, Systemic

Keywords

Vunakizumab; Systemic lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• the percentage of patients achieving an BICLA response at the end of 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)

  From enrollment to the end of treatment at 24 weeks

Secondary Outcomes (7)

• 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

Study Arms (1)

Vunakizumab

EXPERIMENTAL

Drug: Vunakizumab (IL-17A inhibitor)

Interventions

Vunakizumab (IL-17A inhibitor) DRUG

Vunakizumab combined with glucocorticoid therapy: Vunakizumab is administered subcutaneously at 240 mg at weeks 0, 2, and 4, followed by maintenance dosing every 4 weeks at 240 mg per dose.

Vunakizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese SLE Treatment And Research Group: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CN (1)