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Phase 3Completed

A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis (ADVOCATE)

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

Sponsor
Amgen (Industry)
Enrollment
331 enrolled
Conditions
ANCA-Associated Vasculitis
Interventions
Avacopan; Prednisone; Cyclophosphamide; Rituximab; Azathioprine
Ages
children, adults, older adults
Registry
NCT02994927

Full record on ClinicalTrials.gov

From the registry

The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

Primary outcomes

  • Percentage of Subjects Achieving Disease Remission at Week 26
  • Percentage of Subjects Achieving Sustained Disease Remission at Week 52

History

  1. Last registry update

  2. Results first posted

  3. Study completion

  4. Primary completion

  5. Started

  6. Registered