NCT07904806Not yet recruitingPhase 2
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
A Phase 2, Randomized, Double-blind, Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of VIS954 Administered Subcutaneously in Adult Participants With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 23 Oct 2026
- Start date
- 15 Dec 2026
- Primary completion date
- 20 Nov 2029
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT07904806
- EU CT number
- 2025-524968-38-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From 15 Dec 2026 to the primary completion date, 20 Nov 2029
- No sites listed in no 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
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.