413
Participants
Start Date
November 22, 2010
Primary Completion Date
March 15, 2012
Study Completion Date
November 30, 2016
Apremilast
Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks
Placebo
Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.
Topical or Phototherapy Therapy
Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (\< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie, Vienna
Hopitaux Universitaires de Geneve-HUG, Geneva
Bispebjerg Hospital, Copenhagen
University of Zurich Hospital, Zurich
Hospital Universitari Germans Trias i Pujol, Badalona (Barcelona)
Hospital Abente y Lago, A Coruña
Hautarztpraxis Mahlow, Mahlow
Virginia Medical Research, Norfolk
Universitäts-Hautklinik Kiel, Kiel
Centre d'lnvestigation Clinique, Hopital Jean Minjoz, Besançon
PMG Research of Winston-Salem, Winston-Salem
Wake Forest University Health Sciences, Winston-Salem
Hospital Universitario La Princesa, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Fundacion Alcorcon, Alcorcón
Radiant Research, Inc., Anderson
MedaPhase Inc., Newnan
Advanced Medical Research, Atlanta
Larrey University Hospital, Toulouse
Florida Academic Dermatology Center, Miami
Hospital haut leveque, Pessac
A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia, Verona
Northwestern University Northwestern Medical Faculty Foundation, Chicago
Burke Pharmaceutical Research, Hot Springs
Modern Research Associates PLLC, Dallas
Center for Clinical Studies, Houston
Center for Clinical Studies, Webster
Austin Dermatology Associates, Austin
Universita degli Studi di Napoli Federico II, Napoli
Arizona Skin and Laser Therapy Inst., Ltd., Phoenix
Dermatology Research Associates, Los Angeles
Clinical Science Institute, Santa Monica
Bakersfield Dermatology and Skin Cancer Medical Group, Bakersfield
Tufts Medical Center, Boston
Clinical Partners, LLC, Johnston
Northwest Dermatology and Laser Centre, Calgary
Stratica Medical, Edmonton
NewLab Clinical Research, St. John's
Skin Center for Dermatology, Peterborough
Windsor Clinical Research Inc., Winsor
Q & T Research Sherbrooke Inc., Sherbrooke
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ, Québec
Dr. med. Beatrice Gerlach, Dresden
Universitatsklinikum Hamburg-Eppendorf / IVDP, Hamburg
Universitatsklinikum Leipzig, Leipzig
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica, Rome
Lead Sponsor
Amgen
INDUSTRY