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A Phase 3B, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study Of The Efficacy And Safety Of Apremilast (CC-10004), Etanercept, And Placebo, In Subjects With Moderate To Severe Plaque Psoriasis
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
This is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy, study of the efficacy and safety of apremilast, etanercept, and placebo, in adults with moderate to severe plaque psoriasis. 250 participants will be randomized 1:1:1 to the three treatment groups. All subjects will receive both tablets and injections through Week 16. The study will consist of four phases: * Screening Phase - up to 35 days * Double-blind Placebo-controlled Phase - Weeks 0-16 * Apremilast Extension Phase - Weeks 16-104 * Post-treatment Observational Follow-up Phase During the double-blind, placebo-controlled phase, subjects will receive treatment with one of the following: * apremilast (APR) 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections (1 mL x 2 injections SC), or * etanercept (ETN) 50 mg evaluator/subject-blinded subcutaneous (SC) once weekly (QW) injections (2 x 25 mg) plus placebo tablets orally twice a day (BID), or * placebo tablets and evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections. All subjects will be asked to participate in a 4-week Post-treatment Observational Follow-up Phase either upon completion of the study or upon discontinuation of investigational product for those subjects who terminate the study early.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Research Center
Phoenix, Arizona, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
University of California Irvine-Department of Dermatology
Irvine, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Horizons Clinical Research
Denver, Colorado, United States
George Washington University
Washington D.C., District of Columbia, United States
Florida Center for Dermatology, PA
Jacksonville, Florida, United States
Florida Academic Dermatology Center
Miami, Florida, United States
International Dermatology Research
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Start Date
October 1, 2012
Primary Completion Date
July 3, 2014
Completion Date
April 4, 2016
Last Updated
March 15, 2022
250
ACTUAL participants
Apremilast
DRUG
Etanercept
DRUG
Placebo tablet
DRUG
Placebo injection
DRUG
Lead Sponsor
Amgen
NCT07295509
NCT07449234
NCT07116967
Data Source & Attribution
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