A Phase 2 interventional study of VIS954 and Standard Of Care (SOC) in Antineutrophil Cytoplasmic Antibody-associated Vasculitis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment
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).
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's planned enrollment of 75 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 295 studies on the registry; 18 are open to participants now.
Of its 106 completed or terminated interventional studies of FDA-regulated products, 71 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Key Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Drug: VIS954 · Drug: Standard Of Care (SOC)
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.
Drug: Standard Of Care (SOC) · Drug: Placebo
SC injection
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.
SC injection
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.
Time frame: 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.
Time frame: Baseline through Week 24
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
TEAEs will be classified according to severity and seriousness and summarized through Week 52. Participants may experience more than one TEAE.
Time frame: Baseline through Week 52
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Change from baseline in estimated glomerular filtration rate through Week 24.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 24
Change From Baseline in Urine Protein-to-Creatinine Ratio
Time frame: 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.
Time frame: Baseline through Week 24
Proportion of Participants With Complete Resolution of Hematuria
Percentage of participants with complete resolution of hematuria through Week 24.
Time frame: Up to Week 24
Cumulative Oral Glucocorticoid Dose
Cumulative oral glucocorticoid dose (in milligrams \[mg\]) at Week 24.
Time frame: 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.
Time frame: Baseline through Week 52
Serum Pharmacokinetic (PK) Concentrations Over Time
Evaluation of serum PK concentrations over time.
Time frame: Baseline through Week 52
VIS954 Percentage Receptor Occupancy
Pharmacodynamic parameter to characterize and evaluate VIS954 binding to target receptor.
Time frame: 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.
Time frame: Baseline through Week 52
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Access criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
Data sharing details ↗ · clinical-trials.otsuka.com
Start is estimated for Dec 2026; primary completion for Nov 2029, 35 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: VIS954
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
Otsuka Pharmaceutical Development & Commercialization, Inc. →