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

Conditions

• ANCA-Associated Vasculitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avacopan — DRUG
  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.
• Prednisone — DRUG
  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.
• Cyclophosphamide — DRUG
  Orally or intravenously administered
• Rituximab — BIOLOGICAL
  Intravenously administered
• Azathioprine — DRUG
  Orally administered

Study Details

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.

Key Dates

Start date

Mar 15, 2017

Status verified

Mar 2025

Primary completion

Sep 7, 2019

Completion

Nov 1, 2019

Study Design

Enrollment

331 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Prednisone group
  Avacopan-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone.
• Experimental: Avacopan group
  Avacopan plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo.

Primary Outcome Measure

Percentage of Subjects Achieving Disease Remission at Week 26 [ Time Frame: Week 26 ]

Locations (41)

Find similar trials in Huntsville, AL

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