Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

PHASE3CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

October 1, 2012

Primary Completion Date

July 3, 2014

Study Completion Date

April 4, 2016

Conditions
PsoriasisPsoriatic Arthritis
Interventions
DRUG

Apremilast

Apremilast 30 mg tablet orally BID

DRUG

Etanercept

Etanercept 50 mg evaluator/subject-blinded SC QW injection

DRUG

Placebo tablet

Placebo tablets BID

DRUG

Placebo injection

Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)

Trial Locations (82)

1001

Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre, Riga

1011

Adoria Ltd, Riga

Family Doctor's Indra's Kenina's Practice, Riga

1200

Cliniques Universitaires St-Luc, Brussels

1307

University Hospital Carl Gustav Carus, Dresden

2125

Arija's Ancane's Family Doctor Private Practice, Baldone

2164

LTD M & M centrs, Ādaži

3002

Sinclair Dermatology, East Melbourne

3201

Health Center of Talsi Ltd, Talsi

4000

University Hospital of Liege CHU Liege, Liège

4102

Veracity Clinical Research, Woolloongabba

4103

UniversitatsKlinikum Leipzig A.o.R., Leipzig

4217

The Skin Centre, Benowa

5000

Allergo-Derm Bakos Kft., Szolnok

5011

Rheumatology unit Ward 5C Queen Elizabeth Hospital, Woodville

6100

Gairdner Hospital, Victoria Park

6160

Fremantle Dermatology, Fremantle

7100

Tolna Megyei Balassa Janos Korhaz, Szekszárd

9000

University Hospital Ghent, Ghent

10016

NYU Department of Dermatology, New York

10117

Psoriasis Study Center, Berlin

10827

Dermatologische Praxis, Berlin

11375

Forest Hills Dermatology Group, Forest Hills

13125

Klinische Forschung Berlin - Buch GmbH, Berlin

15213

University of Pittsburgh Medical Center, Pittsburgh

15831

Gemeinschaftspraxis Mahlow, Mahlow

20037

George Washington University, Washington D.C.

20354

SCIderm GmbH, Hamburg

20850

Lawrence Green, MD, LLC, Rockville

23507

Virginia Clinical Research Inc, Norfolk

23538

Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein, Lübeck

24501

The Education and Research Foundation, Lynchburg

27104

Wake Forest University Health Sciences, Winston-Salem

27516

University of North Carolina, Chapel Hill

27710

Duke University Medical Center, Durham

30022

Atlanta Dermatology, Vein and Research Center, PC, Alpharetta

32204

Florida Center for Dermatology, PA, Jacksonville

33136

Florida Academic Dermatology Center, Miami

33144

International Dermatology Research, Miami

34471

Renstar Medical Research, Ocala

37215

Tennesse Clinical Research Center, Nashville

42275

Praxis fr Dermatologie und Venerologie, Wuppertal

43230

Ohio State University Medical Center, Columbus

44106

University Hospitals Case Medical Center, Cleveland

46256

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

48143

University Hospital Munster, Münster

50417

Dermatology Clinic of Tartu University Hospital, Tartu

54701

Dermamedica, Náchod

60077

NorthShore University HealthSystem, Skokie

60590

University Hospital Frankfurt, Frankfurt

62702

Southern Illinois University School of Medicine, Springfield

65526

South Estonian Hospital Ltd, Meegomäe Village, Võru County

69115

Universitatsklinikum Heidelberg, Heidelberg

70605

Dermatology and Advanced Aesthetics, Lake Charles

78745

Teckton Research, Austin

80220

Horizons Clinical Research, Denver

85023

Arizona Research Center, Phoenix

91054

Hautklinik Universitatsklinikum Erlangen, Erlangen

92122

University of California San Diego Medical Center, San Diego

92697

University of California Irvine-Department of Dermatology, Irvine

93309

Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield

98101

Dermatology Associates of Seattle, Seattle

03756

Dartmouth Hitchcock Medical Center, Lebanon

08873

Robert Wood Johnson Medical School, Somerset

B3H 1Z4

Eastern Canada Cutaneous Research Associates Ltd, Halifax

K9J 5K2

Skin Center for Dermatology, Peterborough

N2J 1C4

K. Papp Clinical Research Inc., Waterloo

H3Z 2S6

Siena Medical Research, Montreal

J1H 4J6

Q & T Research Sherbrooke Inc., Sherbrooke

430 04

Dorothea, Kožní a korektivne dermatologické pracovište, Chomutov

530 02

Východoceské dermatologické centrum Homea s.r.o., Pardubice

532 03

Krajská nemocnice Pardubice, Kožní oddelení, Pardubice

568 02

Dermatovenerologicka ambulance, Svitavy

400 10

Koznia zilni ambulance, Ústí nad Labem

D-20246

Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center, Hamburg

1105 AZ

Academic Medical Center, Amsterdam

6500HB

Radboud University Medical Centre, Nijmegen

CF14 4XN

University Hospital of Wales, Cardiff

LS7 4SA

Leeds Teaching Hospitals Trust, Leeds

E11 1NR

Whipps Cross University Hospital, London

SM5 1AA

St Helier Hospital, London

CV10 7DJ

George Eliot Hospital, Nuneaton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY