Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
NCT ID: NCT01690299
Last Updated: 2022-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2012-10-01
2016-04-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apremilast 30 mg plus placebo injection
Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections
Apremilast
Apremilast 30 mg tablet orally BID
Placebo injection
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Etanercept 50 mg plus placebo tablet
Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID
Etanercept
Etanercept 50 mg evaluator/subject-blinded SC QW injection
Placebo tablet
Placebo tablets BID
Oral placebo tablets plus SC placebo injections
Identically matching placebo tablets and evaluator/subject-blinded SC injections
Placebo tablet
Placebo tablets BID
Placebo injection
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Interventions
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Apremilast
Apremilast 30 mg tablet orally BID
Etanercept
Etanercept 50 mg evaluator/subject-blinded SC QW injection
Placebo tablet
Placebo tablets BID
Placebo injection
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to Screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy
* Had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis.
* No prior exposure to biologics for treatment of psoriatic arthritis or psoriasis
Exclusion Criteria
* Pregnant or breast feeding.
* Have failed more than 3 systemic agents for treatment of psoriasis.
* History of allergy to any component of the investigational product (IP), including human immunoglobulin (Ig) proteins or allergy to etanercept.
* Hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
* Latent, active tuberculosis (TB) or inadequately treated TB; nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, Clostridium difficile).
* Have a history of, or ongoing, chronic or recurrent infectious disease
* Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months before first administration of IP, or through Week 20 during the study.
* Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.
* History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
* Active substance abuse or a history of substance abuse within 6 months prior to Screening.
* Malignancy or history of malignancy, except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and cervical intraepithelial neoplasia \[CIN\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.
* Psoriasis flare or rebound within 4 weeks prior to Screening.
* Topical therapy within 2 weeks of randomization or systemic therapy for psoriasis within 4 weeks prior to randomization
* Use of phototherapy within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
* Any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
* Prior treatment with apremilast or etanercept.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, United States
Lawrence Green, MD, LLC
Rockville, Maryland, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Robert Wood Johnson Medical School
Somerset, New Jersey, United States
Forest Hills Dermatology Group
Forest Hills, New York, United States
NYU Department of Dermatology
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Tennesse Clinical Research Center
Nashville, Tennessee, United States
Teckton Research
Austin, Texas, United States
The Education and Research Foundation
Lynchburg, Virginia, United States
Virginia Clinical Research Inc
Norfolk, Virginia, United States
Dermatology Associates of Seattle
Seattle, Washington, United States
The Skin Centre
Benowa, Queensland, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Gairdner Hospital
Victoria Park, , Australia
Rheumatology unit Ward 5C Queen Elizabeth Hospital
Woodville, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
University Hospital Ghent
Ghent, , Belgium
University Hospital of Liege CHU Liege
Liège, , Belgium
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, Canada
Skin Center for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
Siena Medical Research
Montreal, Quebec, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Dorothea, Kožní a korektivne dermatologické pracovište
Chomutov, , Czechia
Dermamedica
Náchod, , Czechia
Východoceské dermatologické centrum Homea s.r.o.
Pardubice, , Czechia
Krajská nemocnice Pardubice, Kožní oddelení
Pardubice, , Czechia
Dermatovenerologicka ambulance
Svitavy, , Czechia
Koznia zilni ambulance
Ústí nad Labem, , Czechia
South Estonian Hospital Ltd
Meegomäe Village, Võru County, , Estonia
Dermatology Clinic of Tartu University Hospital
Tartu, , Estonia
Psoriasis Study Center
Berlin, , Germany
Dermatologische Praxis
Berlin, , Germany
Klinische Forschung Berlin - Buch GmbH
Berlin, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Hautklinik Universitatsklinikum Erlangen
Erlangen, , Germany
University Hospital Frankfurt
Frankfurt, , Germany
SCIderm GmbH
Hamburg, , Germany
Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center
Hamburg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
UniversitatsKlinikum Leipzig A.o.R.
Leipzig, , Germany
Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein
Lübeck, , Germany
Gemeinschaftspraxis Mahlow
Mahlow, , Germany
University Hospital Munster
Münster, , Germany
Praxis fr Dermatologie und Venerologie
Wuppertal, , Germany
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Allergo-Derm Bakos Kft.
Szolnok, , Hungary
LTD M & M centrs
Ādaži, , Latvia
Arija's Ancane's Family Doctor Private Practice
Baldone, , Latvia
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
Riga, , Latvia
Adoria Ltd
Riga, , Latvia
Family Doctor's Indra's Kenina's Practice
Riga, , Latvia
Health Center of Talsi Ltd
Talsi, , Latvia
Academic Medical Center
Amsterdam, , Netherlands
Radboud University Medical Centre
Nijmegen, , Netherlands
University Hospital of Wales
Cardiff, , United Kingdom
Leeds Teaching Hospitals Trust
Leeds, , United Kingdom
Whipps Cross University Hospital
London, , United Kingdom
St Helier Hospital
London, , United Kingdom
George Eliot Hospital
Nuneaton, , United Kingdom
Countries
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References
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Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.
Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14.
Reich K, Gooderham M, Green L, Bewley A, Zhang Z, Khanskaya I, Day RM, Goncalves J, Shah K, Piguet V, Soung J. The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE). J Eur Acad Dermatol Venereol. 2017 Mar;31(3):507-517. doi: 10.1111/jdv.14015. Epub 2016 Dec 19.
Other Identifiers
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2012-000859-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-10004-PSOR-010
Identifier Type: -
Identifier Source: org_study_id
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