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NCT05376319

PR3-AAV Resilient Remission or PRRR

Terminated Phase 2 Results posted Last updated 31 July 2024
What this trial tests

Phase 2 trial testing Obinutuzumab in Granulomatosis With Polyangiitis in 6 participants. Terminated before completion.

Timeline
30 June 2023
Primary endpoint
7 May 2024
7 May 2024

Quick facts

Lead sponsorMayo Clinic
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment6
Start date30 June 2023
Primary completion7 May 2024
Estimated completion7 May 2024
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Granulomatosis With Polyangiitis or Microscopic Polyangiitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA. Primary · 6 months

Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper. Seronegativity for ANCA is defined as a negative test for antibodies directed against serine proteinase 3 (i.e., a negative PR3-ANCA assay).

GroupValue95% CI
Intravenous Dose of Obinutuzumab0
Intravenous Dose of Rituximab0
Number of Patients to Achieve Sustained Complete Remission 6 Months Secondary · 6 months

Complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) of 0 without glucocorticoids beyond the prescribed prednisone taper.

GroupValue95% CI
Intravenous Dose of Obinutuzumab1
Intravenous Dose of Rituximab0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from baseline to end of study for a total of approximately eighteen months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intravenous Dose of Obinutuzumab
Serious: 1/2 (50%)
Deaths: 0/2
Intravenous Dose of Rituximab
Serious: 0/4 (0%)
Deaths: 0/4

Serious adverse events (1 terms)

ReactionSystemIntravenous Dose of Obinut…Intravenous Dose of Rituxi…
SepsisInfections and infestations
Other adverse events (25 terms — click to expand)

ReactionSystemIntravenous Dose of Obinut…Intravenous Dose of Rituxi…
Hot FlashesReproductive system and breast disorders
RashSkin and subcutaneous tissue disorders
Bilateral leg crampsMusculoskeletal and connective tissue disorders
ChillsGeneral disorders
ConjunctivitisEye disorders
Covid-19Infections and infestations
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders
Vaginal Yeast InfectionReproductive system and breast disorders
ShinglesInfections and infestations
AnemiaBlood and lymphatic system disorders
DizzinessNervous system disorders
Voice lossRespiratory, thoracic and mediastinal disorders
Worsening tinnitus (left ear)Ear and labyrinth disorders
Lower back painMusculoskeletal and connective tissue disorders
Right-sided pleuritic abdominal painGastrointestinal disorders
Bilateral thigh discomfortMusculoskeletal and connective tissue disorders
Bilateral knee acheMusculoskeletal and connective tissue disorders
Bilateral ankle acheMusculoskeletal and connective tissue disorders
SinusitisInfections and infestations
HyperkalemiaMetabolism and nutrition disorders
Hypertension, grade 3Blood and lymphatic system disorders
Bilateral peripheral ulcerative keratitisEye disorders
FatigueGeneral disorders
CoughRespiratory, thoracic and mediastinal disorders
HypercalcemiaMetabolism and nutrition disorders

Most-reported serious reactions: Sepsis.

Data from ClinicalTrials.gov NCT05376319 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab for the treatment of proteinase 3 Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (PR3-AAV).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Implications of rituximab pharmacokinetic and pharmacodynamic alterations in various immune-mediated glomerulopathies and potential anti-CD20 therapy alternatives.
    Hartinger JM, Kratky V, Hruskova Z, Slanar O, et al · · 2022 · cited 30× · PMID 36420256 · DOI 10.3389/fimmu.2022.1024068
  2. Clinical Insights and Therapeutic Strategies for the Treatment of Interstitial Lung Disease in Patients with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Current Trends and Future Directions.
    Fijolek J, Sniady A. · · 2025 · cited 1× · PMID 40649005 · DOI 10.3390/jcm14134631
  3. Evolving Therapeutic Strategies in ANCA-Associated Vasculitis: Current Standards and Emerging Targets for GPA and MPA
    Dal Pozzolo R, Iorio L, Davanzo F, Zanatta E, et al · · 2026
  4. Practical Management of ANCA-Associated Vasculitis: A Clinician’s Perspective
    Stacey H, Francis L, Smith R, Jones R. · · 2024

Verify or expand the search:

Other trials of Obinutuzumab

Trials testing the same drug.

Other recruiting trials for Granulomatosis With Polyangiitis

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05376319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing