A Randomized, Double-blind, Placebo-controlled Phase 4 Clinical Trial to Evaluate the Long-term Safety and Efficacy of Avacopan in Participants With Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Amgen
Summary
The primary objective of this study is to evaluate the long-term safety of avacopan in participants with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants has provided informed consent before initiation of any study-specific activities/procedures. * Newly diagnosed or relapse of granulomatosis with polyangiitis or microscopic polyangiitis, consistent with Chapel-Hill Consensus Conference definitions (Jennette et al, 2013), where induction treatment with cyclophosphamide or rituximab is needed. * Age \>/= 18 years (or \>/= legal age within the country if it is older than 18 years). * Positive test for anti-positive antiproteinase 3 or antimyeloperoxidase (current or historic) antibodies. * At least 1 Birmingham…
Interventions
- DrugAvacopan
Administered orally.
- DrugPlacebo
Administered orally.
- DrugStandard of Care
All participants will receive SoC background immunosuppressive therapy for induction and maintenance, at the discretion of the Investigator and as supported by current guidelines, product labels and local practices and informed by the individual participant's clinical condition, preferences, and values.
Locations (76)
- Orthopedic Physicians AlaskaAnchorage, Alaska
- Scottsdale Healthcare at Shea - HonorHealthScottsdale, Arizona
- Southwest Kidney InstituteSurprise, Arizona
- Unity HealthSearcy, Arkansas
- Medvin Clinical ResearchCovina, California
- Palo Alto Medical Foundation FremontFremont, California