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

Detailed criteria

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. Note: For participants receiving azathioprine, mycophenolate, or methotrexate, these medications must be discontinued prior to initiation of induction treatment. Participants receiving, or planned to receive combined ri…

Interventions

Drug
Avacopan
Administered orally.
Drug
Placebo
Administered orally.
Drug
Standard 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 (83)

Orthopedic Physicians Alaska
Anchorage, Alaska
Scottsdale Healthcare at Shea - HonorHealth
Scottsdale, Arizona
Southwest Kidney Institute
Surprise, Arizona
Unity Health
Searcy, Arkansas
Medvin Clinical Research
Covina, California
Palo Alto Medical Foundation Fremont
Fremont, California