Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody‑associated Vasculitis

Sponsor ID
381-201-00020
Clinicaltrials.gov ID
NCT07904806
EudraCT ID
N/A
EUCTIS ID
2025-524968-38-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
844-687-8522 or [email protected]
Will Be Recruiting
Sponsor ID
381-201-00020
Trial Details
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Age
18+ years
Therapeutic Area
  • Unmapped
    • Sex
    Female & Male
    Trial Dates
    Dec 2026 - Nov 2029
    Healthy Volunteers
    No
    • Key Inclusion Criteria
    • Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
    • Participant must have a new diagnosis or a relapse of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), specifically granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
    • Participant must have evidence of ANCA antibodies (anti-myeloperoxidase \[MPO\] or anti-proteinase 3 \[PR3\]) associated with AAV.
    • Participant must have active AAV with new or worsening signs or symptoms documented, as demonstrated by established disease activity criteria.
    • Key Exclusion Criteria
    • Participant must not require advanced organ support for severe disease at screening.
    • Participant must not have a life-threatening illness requiring intensive care at screening.
    • Participant must not have another autoimmune disease that could affect evaluation of the study treatment, such as eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus (lupus), IgA vasculitis, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (anti-GBM) disease, cryoglobulinemic vasculitis, or suspected drug-induced AAV.
    • Participant must not have received certain immune-modifying treatments within 6 months before screening, including avacopan, B-cell-targeted therapies, chimeric antigen receptor T-cell (CAR-T) cell therapies, belimumab, tocilizumab, or similar biologic therapies that affect the immune system.
    • Participant must not be receiving azathioprine, mycophenolate mofetil, or methotrexate unless they are willing and able to stop these medications before starting study treatment.
    • Participant must not have received rituximab, cyclophosphamide, or another B-cell-depleting therapy within 6 months before screening, except when rituximab or cyclophosphamide was administered as part of standard-of-care treatment.

    Study Summary

    This is a phase 2, double-blind, randomized, controlled, multicenter trial evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of 2 VIS954 dosing regimens in patients with moderate to severe acute anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV).

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: VIS954
    Type
    Interventional
    Masking
    Double
    Estimated Enrollment
    75
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Key Inclusion Criteria
    • 1. Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Key Inclusion Criteria
    • Participant must be at least 18 years of age or have reached the legal age of consent in their country, whichever is higher.
    • Participant must have a new diagnosis or a relapse of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), specifically granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
    • Participant must have evidence of ANCA antibodies (anti-myeloperoxidase \[MPO\] or anti-proteinase 3 \[PR3\]) associated with AAV.
    • Participant must have active AAV with new or worsening signs or symptoms documented, as demonstrated by established disease activity criteria.
    • Key Exclusion Criteria
    • Participant must not require advanced organ support for severe disease at screening.
    • Participant must not have a life-threatening illness requiring intensive care at screening.
    • Participant must not have another autoimmune disease that could affect evaluation of the study treatment, such as eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus (lupus), IgA vasculitis, rheumatoid vasculitis, Sjögren's syndrome, anti-glomerular basement membrane (anti-GBM) disease, cryoglobulinemic vasculitis, or suspected drug-induced AAV.
    • Participant must not have received certain immune-modifying treatments within 6 months before screening, including avacopan, B-cell-targeted therapies, chimeric antigen receptor T-cell (CAR-T) cell therapies, belimumab, tocilizumab, or similar biologic therapies that affect the immune system.
    • Participant must not be receiving azathioprine, mycophenolate mofetil, or methotrexate unless they are willing and able to stop these medications before starting study treatment.
    • Participant must not have received rituximab, cyclophosphamide, or another B-cell-depleting therapy within 6 months before screening, except when rituximab or cyclophosphamide was administered as part of standard-of-care treatment.

    Locations

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    January 2026 01US25EUC0489

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