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Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 31, 2025 to Nov 20, 2026
    • Study completion date: Apr 1, 2027 to Dec 1, 2027
    • Start date changed from estimate of Apr 1, 2025 to May 19, 2025
    v3
  2. Notable Phase: Phase 1/2 to Phase 1
    • Secondary endpoints revised (7)
    • Study title shortened, about 3 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06881290
Lead Sponsor Chinese SLE Treatment And Research Group
Conditions
(from sponsor)
Lupus Erythematosus, Systemic
Related terms Lupus Erythematosus, Systemic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov