Antineutrophil Cytoplasmic Antibody-associated VasculitisPhase 2NCT07904806
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
A Phase 2 study testing VIS954 in people with Antineutrophil Cytoplasmic Antibody-associated Vasculitis, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antineutrophil Cytoplasmic Antibody-associated Vasculitis
- What is being tested?
- VIS954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 20 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
- Being tested
- VIS954, Standard Of Care (SOC), Placebo
- Keywords
- ANCA, AAV
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS954Drug
SC injection
Standard Of Care (SOC)Drug
Glucocorticoids and rituximab or cyclophosphamide will be administered as standard-of-care induction therapy at the investigator's discretion and in accordance with local practice and applicable treatment guidelines.
PlaceboDrug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| VIS954 High Dose + SOC | Experimental | Participants will receive VIS954 High Dose subcutaneous (SC) injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with standard of care (SOC) treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. Receives: Drug: VIS954; Drug: Standard Of Care (SOC) |
| VIS954 Low Dose + SOC | Experimental | Participants will receive VIS954 Low Dose subcutaneous injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with SOC treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. Receives: Drug: VIS954; Drug: Standard Of Care (SOC) |
| Placebo + SOC | Placebo comparator | Participants will receive VIS954 Placebo subcutaneous injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with SOC treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. Receives: Drug: Standard Of Care (SOC); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants in Remission at Week 24
A participant is considered to be in remission at Week 24 if the Birmingham Vasculitis Activity Score version 3 (BVAS v3) is 0 at Week 24 and no rescue medication was required. BVAS v3 is a measure of vasculitis disease activity, with a score of 0 indicating no active disease.
Measured: Week 24
Incidence of Treatment-Emergent Adverse Events (TEAEs) Through Week 24
TEAEs will be classified according to severity and seriousness and summarized through Week 24. Participants may experience more than one TEAE.
Measured: Baseline through Week 24
Secondary outcomes (18)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Through Week 24
Measured: Baseline through Week 24
Number of Participants With Clinically Significant Changes in Vital Signs Through Week 24
Measured: Baseline through Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 24
Measured: Baseline through Week 24
Number of Participants With Clinically Significant Injection Site Reactions Through Week 24
Measured: Baseline through Week 24
Incidence of TEAEs Through Week 52
TEAEs will be classified according to severity and seriousness and summarized through Week 52. Participants may experience more than one TEAE.
Measured: Baseline through Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in estimated glomerular filtration rate through Week 24.
Measured: Baseline through Week 24
Time to Remission
Time to remission is defined as the time to achieve a BVAS v3 score of 0. BVAS v3 measures disease activity in systemic vasculitis, with higher scores indicating greater disease activity. A score of 0 indicates no active disease.
Measured: Up to Week 24
Duration of Remission
Duration of Remission is defined as the time from the first achievement of a BVAS v3 score of 0 on or before Week 24 to the first major relapse. Relapse is classified as major or minor based on recurrent disease activity following remission, as assessed using BVAS v3 criteria.
Measured: Up to Week 24
Proportion of Participants Experiencing a Major or Minor Relapse After Achieving Remission
Relapse is classified as major or minor based on recurrent disease activity following remission, as assessed using BVAS v3 criteria.
Measured: Up to Week 24
Proportion of Participants in Glucocorticoid-Free Remission at Week 24
Glucocorticoid-free remission is defined as a BVAS v3 score of 0 at Week 24 and no systemic glucocorticoid use after Week 20 through Week 24.
Measured: Week 24
Change From Baseline in Urine Protein-to-Creatinine Ratio
Measured: Baseline through Week 24
Change From Baseline in Hematuria
Assesses the change from baseline through Week 24 in the amount of blood present in the urine (hematuria), based on laboratory measurements.
Measured: Baseline through Week 24
Proportion of Participants With Complete Resolution of Hematuria
Percentage of participants with complete resolution of hematuria through Week 24.
Measured: Up to Week 24
Cumulative Oral Glucocorticoid Dose
Cumulative oral glucocorticoid dose (in milligrams [mg]) at Week 24.
Measured: Week 24
Incidence of Infection-Related Treatment-Emergent Adverse Events through Week 52
Incidence of Infection-Related Treatment-Emergent Adverse Events will be summarized through Week 52. Participants may experience more than one infection-related TEAE.
Measured: Baseline through Week 52
Serum Pharmacokinetic (PK) Concentrations Over Time
Evaluation of serum PK concentrations over time.
Measured: Baseline through Week 52
VIS954 Percentage Receptor Occupancy
Pharmacodynamic parameter to characterize and evaluate VIS954 binding to target receptor.
Measured: Baseline through Week 52
Number of Participants With Serum Anti-Drug Antibodies (ADA) Over Time
The proportion of participants with treatment-emergent anti-drug antibodies (ADA) in serum will be assessed at scheduled time points throughout the study.
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion20 Nov 2029 (estimated)
- Study completion20 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antineutrophil Cytoplasmic Antibody-associated VasculitisStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904806
- Sponsor's protocol ID
- 381-201-00020
- Other IDs
- 2025-524968-38-00, 1014436, 2025
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07904806
- Acronym / sponsor ID
- 381-201-00020
- Keywords
- ANCA, AAV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 20 Nov 2029 (estimated)
- Study completion
- 20 Nov 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VIS954 High Dose + SOC | Experimental | Drug: VIS954, Drug: Standard Of Care (SOC)Participants will receive VIS954 High Dose subcutaneous (SC) injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with standard of care (SOC) treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. |
| VIS954 Low Dose + SOC | Experimental | Drug: VIS954, Drug: Standard Of Care (SOC)Participants will receive VIS954 Low Dose subcutaneous injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with SOC treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. |
| Placebo + SOC | Placebo comparator | Drug: Standard Of Care (SOC), Drug: PlaceboParticipants will receive VIS954 Placebo subcutaneous injections and SOC treatment throughout the Induction Phase; Then VIS954 High Dose subcutaneous injections with SOC treatment according to the Investigator's discretion throughout the Maintenance Phase for up to Week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIS954SC injection | Drug | VIS954 High Dose + SOC, VIS954 Low Dose + SOC |
| Standard Of Care (SOC)Glucocorticoids and rituximab or cyclophosphamide will be administered as standard-of-care induction therapy at the investigator's discretion and in accordance with local practice and applicable treatment guidelines. | Drug | Placebo + SOC, VIS954 High Dose + SOC, VIS954 Low Dose + SOC |
| PlaceboSC injection | Drug | Placebo + SOC |
Primary outcome
Proportion of Participants in Remission at Week 24
Time frame: Week 24
A participant is considered to be in remission at Week 24 if the Birmingham Vasculitis Activity Score version 3 (BVAS v3) is 0 at Week 24 and no rescue medication was required. BVAS v3 is a measure of vasculitis disease activity, with a score of 0 indicating no active disease.
Incidence of Treatment-Emergent Adverse Events (TEAEs) Through Week 24
Time frame: Baseline through Week 24
TEAEs will be classified according to severity and seriousness and summarized through Week 24. Participants may experience more than one TEAE.
18 secondary outcomes
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Through Week 24
Time frame: Baseline through Week 24
Number of Participants With Clinically Significant Changes in Vital Signs Through Week 24
Time frame: Baseline through Week 24
Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 24
Time frame: Baseline through Week 24
Number of Participants With Clinically Significant Injection Site Reactions Through Week 24
Time frame: Baseline through Week 24
Incidence of TEAEs Through Week 52
Time frame: Baseline through Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline through Week 24
Time to Remission
Time frame: Up to Week 24
Duration of Remission
Time frame: Up to Week 24
Proportion of Participants Experiencing a Major or Minor Relapse After Achieving Remission
Time frame: Up to Week 24
Proportion of Participants in Glucocorticoid-Free Remission at Week 24
Time frame: Week 24
Change From Baseline in Urine Protein-to-Creatinine Ratio
Time frame: Baseline through Week 24
Change From Baseline in Hematuria
Time frame: Baseline through Week 24
Proportion of Participants With Complete Resolution of Hematuria
Time frame: Up to Week 24
Cumulative Oral Glucocorticoid Dose
Time frame: Week 24
Incidence of Infection-Related Treatment-Emergent Adverse Events through Week 52
Time frame: Baseline through Week 52
Serum Pharmacokinetic (PK) Concentrations Over Time
Time frame: Baseline through Week 52
VIS954 Percentage Receptor Occupancy
Time frame: Baseline through Week 52
Number of Participants With Serum Anti-Drug Antibodies (ADA) Over Time
Time frame: Baseline through Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial Transparency WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIS954 in people with Antineutrophil Cytoplasmic Antibody-associated Vasculitis, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Otsuka Call Center (844-687-8522, otsuka-professionalservices@otsuka-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants in Remission at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.