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 is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy,
study of the efficacy and safety of apremilast, etanercept, and placebo, in subjects with
moderate to severe plaque psoriasis.
Approximately 240 subjects 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Apremilast Psoriasis Area and Severity Index-75 (PASI)
Proportion of subjects with either apremilast 30 mg twice a day (BID) or placebo who achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from baseline
Week 16
No
Lilia Pineda, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-10004-PSOR-010
NCT01690299
September 2012
August 2015
Name | Location |
---|---|
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
Renstar Medical Research | Ocala, Florida 34474 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
University of California, San Diego | La Jolla, California 92037-1709 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Tennessee Clinical Research Center | Nashville, Tennessee 37221 |
Virginia Clinical Research, Inc | Norfolk, Virginia 23507 |
Dawes Fretzin Clinical Research Group, LLC | Indianapolis, Indiana 46256 |
Arizona Research Center | Phoenix, Arizona 85023 |
Dermatology Associates | Seattle, Washington 98101 |
University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
Florida Academic Dermatology Center | Miami, Florida 33136 |
Dermatology & Advanced Aesthetics | Lake Charles, Louisiana 70605 |
UMDNJ Robert Wood Johnson, Medical School Division | New Brunswick, New Jersey 08901 |
Lawrence Green, MD, LLC | Rockville, Maryland 20850 |
Bakersfield Dermatology and Skin Cancer Medical Group | Bakersfield, California 93309 |
Horizons Clinical Research | Denver, Colorado 80220 |
International Dermatology Research Inc | Miami, Florida 33144 |
Florida Center for Dermatology, PA | St. Augustine, Florida 32086 |
Southern Illinois University School of Medicine Dermatology/Internal Medicine | Springfield, Illinois 62702 |
Robert Wood Johnson Medical School/UMDNJ Department of Dermatology | Somerset, New Jersey 08873 |
Forest Hills Dermatology Group | Forest Hills, New York 11375 |
NYU Department of Dermatology | New York, New York 100616-6402 |
Ohio State University, Division of Dermatology | Gahanna, Ohio 43230 |
Teckton Research | Austin, Texas 78745 |