Clinical Trials

Key Inclusion Criteria:

• Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
• Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
• Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
• Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
• Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.

Key Exclusion Criteria:

• Pregnant or nursing.
• Receipt of a B cell targeted therapy (other than rituximab) at anytime
• Receipt of an investigational biological agent within the past 60 days.
• Required management of acute or chronic infections within the past 60 days.
• Current drug or alcohol abuse or dependence.
• Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of severe allergic reaction to contrast agents or biological medicines.