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

Summary

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.

Conditions

• ANCA-Associated Vasculitis

Interventions

DRUG

Avacopan

Avacopan 30 mg twice daily orally for 52 weeks (364 days): \- Three 10 mg avacopan capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose. Oral prednisone-matching placebo tapering regimen over 20 weeks (140 days): * Prednisone-matching placebo capsules equivalent to 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to a protocol-specified schedule. * Adolescents who weighed ≤37 kg started at a prednisone-matching placebo dose of 30 mg per day.

DRUG

Prednisone

Avacopan-matching placebo twice daily orally for 52 weeks (364 days): \- Three avacopan-matching placebo capsules in the morning, preferably with food, and three in the evening, preferably with food, approximately 12 hours after the morning dose. Oral prednisone tapering regimen over 20 weeks (140 days): * Prednisone 60 mg per day if the subject's body weight was ≥55 kg, or 45 mg per day if the subject's body weight was \<55 kg, starting on Day 1 with tapering according to the protocol-specified schedule. * Adolescents who weighed ≤37 kg started at a prednisone dose of 30 mg per day.

DRUG

Cyclophosphamide

Orally or intravenously administered

BIOLOGICAL

Rituximab

Intravenously administered

DRUG

Azathioprine

Orally administered

Sponsors & Collaborators

• Amgen

  lead INDUSTRY

Principal Investigators

• MD · Amgen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-15

Primary Completion

2019-09-07

Completion

2019-11-01

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• Canada
• Czechia
• Denmark
• France
• Germany
• Hungary
• Ireland
• Italy
• Japan
• Netherlands
• New Zealand
• Norway
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations