PR3-AAV Resilient Remission or PRRR (NCT05376319) | Clinical Trial Compass
TerminatedPhase 2
PR3-AAV Resilient Remission or PRRR
Stopped: Funding was withdrawn by sponsor.
United States6 participantsStarted 2023-06-30
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic polyangiitis).
* Positivity for ANCA, directed against proteinase-3 (PR3)
* Severe newly-diagnosed disease or severe relapsing disease. Severe relapsing disease is defined as at least one major BVAS/WG item or a score ≥ 3 and the investigator deems standard treatment for severe disease is necessary.
* Minimum BVAS/WG of 3
* Relapsing patients must have B cells detectable in the peripheral blood.
* Patients must have completed COVID19 vaccination (including booster if eligible) at least 4 weeks prior to enrollment with a positive spike protein antibody test result. Patients who have recovered from COVID19 prior to screening with a positive spike protein antibody test result but have not been vaccinated are also eligible.
* Female subjects of childbearing potential who are not sterile must agree to use an acceptable method of contraception for 18 months after the last dose of infusion medication. Male subjects who are not sterile whose female partners are of childbearing potential must agree to use an acceptable method of contraception for 180 days after the last dose of infusion medication.
* Females of childbearing potential include any female who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausa…
What they're measuring
1
Number of Patients to Achieve Both Complete Remission and Seronegativity for ANCA.