Actively Recruiting
Long-term Safety and Effectiveness Study of Avacopan with Standard Treatment for ANCA-Associated Vasculitis
Led by Amgen · Updated on 2026-07-23
300
Participants Needed
83
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety of avacopan in adults with antineutrophil cytoplasmic antibody ANCA-associated vasculitis AAV, a condition requiring immunosuppressive therapy. This Phase 4 clinical trial aims to assess how participants tolerate avacopan combined with standard care over an extended period. The study involves participants diagnosed with granulomatosis with polyangiitis or microscopic polyangiitis who need induction treatment with cyclophosphamide or rituximab. Participants are randomly assigned to one of three groups avacopan 30 mg twice daily for five years plus standard care, avacopan 30 mg twice daily for one year followed by placebo twice daily for four years plus standard care, or placebo twice daily for five years plus standard care. Standard care involves background immunosuppressive therapy guided by current guidelines and tailored to each participants needs. Treatments are administered orally, and the study is double-blind to ensure objective assessment. During the study, participants will be monitored regularly for treatment-emergent adverse events, serious adverse events, and changes in vital signs and laboratory tests over up to 60 months. Researchers will also evaluate remission rates, relapse timing, kidney function, health perception scores, and medication use. Safety and efficacy data will be collected through clinical assessments, laboratory evaluations, and questionnaires, with follow-up continuing for the full duration of the trial.
CONDITIONS
Brief Title
A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide informed consent before any study procedures.
- Adults aged 18 years or older.
- Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis requiring induction treatment with cyclophosphamide or rituximab.
- Positive test for antiproteinase 3 or antimyeloperoxidase antibodies (current or historic).
- Presence of specific disease activity as measured by Birmingham Vasculitis Activity Score.
- Estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73 m².
You will not qualify if you...
- Alveolar hemorrhage needing invasive ventilation beyond screening.
- Other multisystem autoimmune diseases that could affect study results.
- Medical conditions requiring ongoing immunosuppressive therapies that may interfere with assessments.
- Received dialysis or plasma exchange within 16 weeks before randomization.
- History of kidney transplant.
- Recent malignancy within 5 years, excluding some treated skin and cervical cancers.
- Active hepatitis B or C, or HIV infection.
- Recent exposure or positive test for active or latent tuberculosis.
- Low white blood cell, neutrophil, or lymphocyte counts.
- Significant liver disease or abnormal liver function tests beyond specified limits.
- Serious infections or certain cardiovascular events within specified recent timeframes.
- Recent use of cyclophosphamide, rituximab, or certain immunosuppressive drugs without required washout periods.
- Recent use of specific biologic therapies or investigational drugs.
- Use of strong or moderate CYP3A4 enzyme inducers unless changed before randomization.
- Prior avacopan treatment without benefit or recent avacopan use before randomization.
Research Team
A
Amgen Call Center
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