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

PHASE3CompletedINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

March 15, 2017

Primary Completion Date

September 7, 2019

Study Completion Date

November 1, 2019

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

Trial Locations (198)

10021

Clinical Trial Site, New York

10032

Clinical Trial Site, New York

11021

Clinical Trial Site, Great Neck

11501

Clinical Trial Site, Mineola

15225

Clinical Trial Site, Pittsburgh

16635

Clinical Trial Site, Duncansville

19104

Clinical Trial Site, Philadelphia

20007

Clinical Trial Site, Washington D.C.

21224

Clinical Trial Site, Baltimore

27103

Clinical Trial Site, Winston-Salem

27599

Clinical Trial Site, Chapel Hill

27834

Clinical Trial Site, Greenville

29406

Clinical Trial Site, Charleston

30322

Clinical Trial Site, Atlanta

32117

Clinical Trial Site, Daytona Beach

33612

Clinical Trial Site, Tampa

35801

Clinical Trial Site, Huntsville

40536

Clinical Trial Site, Lexington

43210

Clinical Trial Site, Columbus

44195

Clinical Trial Site, Cleveland

46202

Clinical Trial Site, Indianapolis

48109

Clinical Trial Site, Ann Arbor

55414

Clinical Trial Site, Minneapolis

55905

Clinical Trial Site, Rochester

60637

Clinical Trial Site, Chicago

63110

Clinical Trial Site, St Louis

66160

Clinical Trial Site, Kansas City

71101

Clinical Trial Site, Shreveport

75235

Clinical Trial Site, Dallas

77030

Clinical Trial Site, Houston

80045

Clinical Trial Site, Aurora

83605

Clinical Trial Site, Meridian

84132

Clinical Trial Site, Salt Lake City

85012

Clinical Trial Site, Phoenix

85032

Clinical Trial Site, Phoenix

90048

Clinical Trial Site, Los Angeles

90404

Clinical Trial Site, Santa Monica

98101

Clinical Trial Site, Seattle

02114

Clinical Trial Site, Boston

02118

Clinical Trial Site, Boston

02903

Clinical Trial Site, Providence

Unknown

Clinical Trial Site, Adelaide

Clinical Trial Site, Auchenflower

Clinical Trial Site, Brisbane

Clinical Trial Site, Clayton

Clinical Trial Site, Concord

Clinical Trial Site, Heidelberg

Clinical Trial Site, Liverpool

Clinical Trial Site, Nambour

Clinical Trial Site, Nedlands

Clinical Trial Site, Randwick

Clinical Trial Site, Saint Albans

Clinical Trial Site, Southport

Clinical Trial Site, St Leonards

Clinical Trial Site, Westmead

Clinical Trial Site, Woolloongabba

Clinical Trial Site, Feldkirch

Clinical Trial Site, Graz

Clinical Trial Site, Innsbruck

Clinical Trial Site, Antwerp

Clinical Trial Site, Brussels

Clinical Trial Site, Leuven

Clinical Trial Site, Liège

Clinical Trial Site, Calgary

Clinical Trial Site, Greenfield Park

Clinical Trial Site, Hamilton

Clinical Trial Site, Montreal

Clinical Trial Site, Québec

Clinical Trial Site, Sherbrooke

Clinical Trial Site, Toronto

Clinical Trial Site, Vancouver

Clinical Trial Site, Olomouc

Clinical Trial Site, Prague

Clinical Trial Site, Aalborg

Clinical Trial Site, Aarhus

Clinical Trial Site, Copenhagen

Clinical Trial Site, Odense

Clinical Trial Site, Roskilde

Clinical Trial Site, Angers

Clinical Trial Site, Bordeaux

Clinical Trial Site, Boulogne-sur-Mer

Clinical Trial Site, Brest

Clinical Trial Site, Bron

Clinical Trial Site, Caen

Clinical Trial Site, Colmar

Clinical Trial Site, Grenoble

Clinical Trial Site, Marseille

Clinical Trial Site, Metz

Clinical Trial Site, Nantes

Clinical Trial Site, Nîmes

Clinical Trial Site, Paris

Clinical Trial Site, Toulouse

Clinical Trial Site, Valenciennes

Clinical Trial Site, Aachen

Clinical Trial Site, Bad Bramstedt

Clinical Trial Site, Berlin

Clinical Trial Site, Cologne

Clinical Trial Site, Dresden

Clinical Trial Site, Essen

Clinical Trial Site, Freiburg im Breisgau

Clinical Trial Site, Fulda

Clinical Trial Site, Hamburg

Clinical Trial Site, Hanover

Clinical Trial Site, Heidelberg

Clinical Trial Site, Jena

Clinical Trial Site, Kirchheim unter Teck

Clinical Trial Site, Leipzig

Clinical Trial Site, Ludwigshafen

Clinical Trial Site, Lübeck

Clinical Trial Site, Mannheim

Clinical Trial Site, Munich

Clinical Trial Site, Tübingen

Clinical Trial Site, Villingen-Schwenningen

Clinical Trial Site, Budapest

Clinical Trial Site, Debrecen

Clinical Trial Site, Cork

Clinical Trial Site, Dublin

Clinical Trial Site, Ancona

Clinical Trial Site, Florence

Clinical Trial Site, Genova

Clinical Trial Site, Milan

Clinical Trial Site, Monza

Clinical Trial Site, Parma

Clinical Trial Site, Reggio Emilia

Clinical Trial Site, Torino

Clinical Trial Site, Udine

Clinical Trial Site, Aichi

Clinical Trial Site, Akita

Clinical Trial Site, Chiba

Clinical Trial Site, Hiroshima

Clinical Trial Site, Hokkaido

Clinical Trial Site, Ishikawa

Clinical Trial Site, Kagawa

Clinical Trial Site, Kanagawa

Clinical Trial Site, Kobe

Clinical Trial Site, Miyazaki

Clinical Trial Site, Nagoya

Clinical Trial Site, Okayama

Clinical Trial Site, Osaka

Clinical Trial Site, Saitama

Clinical Trial Site, Shimane

Clinical Trial Site, Shizuoka

Clinical Trial Site, Tokyo

Clinical Trial Site, Toyama

Clinical Trial Site, Yokohama

Clinical Trial Site, Groningen

Clinical Trial Site, Leiden

Clinical Trial Site, Rotterdam

Clinical Trial Site, Christchurch

Clinical Trial Site, Dunedin

Clinical Trial Site, Grafton

Clinical Trial Site, Hamilton

Clinical Trial Site, Takapuna

Clinical Trial Site, Nordbyhagen

Clinical Trial Site, Oslo

Clinical Trial Site, Tromsø

Clinical Trial Site, Badalona

Clinical Trial Site, Barcelona

Clinical Trial Site, Burela de Cabo

Clinical Trial Site, Lleida

Clinical Trial Site, Madrid

Clinical Trial Site, San Sebastián

Clinical Trial Site, Linköping

Clinical Trial Site, Lund

Clinical Trial Site, Örebro

Clinical Trial Site, Stockholm

Clinical Trial Site, Uppsala

Clinical Trial Site, Basel

Clinical Trial Site, Bern

Clinical Trial Site, Fribourg

Clinical Trial Site, Lausanne

Clinical Trial Site, Sankt Gallen

Clinical Trial Site, Zurich

Clinical Trial Site, Aberdeen

Clinical Trial Site, Basildon

Clinical Trial Site, Birmingham

Clinical Trial Site, Bristol

Clinical Trial Site, Cambridge

Clinical Trial Site, Canterbury

Clinical Trial Site, Cardiff

Clinical Trial Site, Carshalton

Clinical Trial Site, Dorchester

Clinical Trial Site, Dudley

Clinical Trial Site, Exeter

Clinical Trial Site, Glasgow

Clinical Trial Site, Inverness

Clinical Trial Site, Kirkcaldy

Clinical Trial Site, Leeds

Clinical Trial Site, Leicester

Clinical Trial Site, Liverpool

Clinical Trial Site, London

Clinical Trial Site, Manchester

Clinical Trial Site, Newcastle

Clinical Trial Site, Nottingham

Clinical Trial Site, Oxford

Clinical Trial Site, Reading

Clinical Trial Site, Salford

Clinical Trial Site, Westcliff-on-Sea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY