Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis
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
2 other identifiers
interventional
250
11 countries
82
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2012
Typical duration for phase_3
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2014
CompletedResults Posted
Study results publicly available
August 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2016
CompletedMarch 15, 2022
April 1, 2020
1.8 years
September 19, 2012
July 2, 2015
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
Baseline to Week 16
Secondary Outcomes (11)
Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16
Baseline and Week 16
Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Baseline and Week 16
Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Baseline to Week 16
Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Baseline to Week 16
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16
Baseline to Week 16
- +6 more secondary outcomes
Study Arms (3)
Apremilast 30 mg plus placebo injection
EXPERIMENTALApremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections
Etanercept 50 mg plus placebo tablet
EXPERIMENTALEtanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID
Oral placebo tablets plus SC placebo injections
PLACEBO COMPARATORIdentically matching placebo tablets and evaluator/subject-blinded SC injections
Interventions
Apremilast 30 mg tablet orally BID
Etanercept 50 mg evaluator/subject-blinded SC QW injection
Placebo tablets BID
Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Eligibility Criteria
You may qualify if:
- Males or females, ≥ 18 years of age
- 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
You may not qualify if:
- Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (82)
Arizona Research Center
Phoenix, Arizona, 85023, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309, United States
University of California Irvine-Department of Dermatology
Irvine, California, 92697, United States
University of California San Diego Medical Center
San Diego, California, 92122, United States
Horizons Clinical Research
Denver, Colorado, 80220, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Florida Center for Dermatology, PA
Jacksonville, Florida, 32204, United States
Florida Academic Dermatology Center
Miami, Florida, 33136, United States
International Dermatology Research
Miami, Florida, 33144, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, 30022, United States
NorthShore University HealthSystem
Skokie, Illinois, 60077, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Dermatology and Advanced Aesthetics
Lake Charles, Louisiana, 70605, United States
Lawrence Green, MD, LLC
Rockville, Maryland, 20850, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Robert Wood Johnson Medical School
Somerset, New Jersey, 08873, United States
Forest Hills Dermatology Group
Forest Hills, New York, 11375, United States
NYU Department of Dermatology
New York, New York, 10016, United States
University of North Carolina
Chapel Hill, North Carolina, 27516, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27104, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Medical Center
Columbus, Ohio, 43230, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Tennesse Clinical Research Center
Nashville, Tennessee, 37215, United States
Teckton Research
Austin, Texas, 78745, United States
The Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research Inc
Norfolk, Virginia, 23507, United States
Dermatology Associates of Seattle
Seattle, Washington, 98101, United States
The Skin Centre
Benowa, Queensland, 4217, Australia
Sinclair Dermatology
East Melbourne, Victoria, 3002, Australia
Fremantle Dermatology
Fremantle, Western Australia, 6160, Australia
Gairdner Hospital
Victoria Park, 6100, Australia
Rheumatology unit Ward 5C Queen Elizabeth Hospital
Woodville, 5011, Australia
Veracity Clinical Research
Woolloongabba, 4102, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
University Hospital Ghent
Ghent, 9000, Belgium
University Hospital of Liege CHU Liege
Liège, 4000, Belgium
Eastern Canada Cutaneous Research Associates Ltd
Halifax, Nova Scotia, B3H 1Z4, Canada
Skin Center for Dermatology
Peterborough, Ontario, K9J 5K2, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, N2J 1C4, Canada
Siena Medical Research
Montreal, Quebec, H3Z 2S6, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 4J6, Canada
Dorothea, Kožní a korektivne dermatologické pracovište
Chomutov, 430 04, Czechia
Dermamedica
Náchod, 54701, Czechia
Východoceské dermatologické centrum Homea s.r.o.
Pardubice, 530 02, Czechia
Krajská nemocnice Pardubice, Kožní oddelení
Pardubice, 532 03, Czechia
Dermatovenerologicka ambulance
Svitavy, 568 02, Czechia
Koznia zilni ambulance
Ústí nad Labem, 400 10, Czechia
South Estonian Hospital Ltd
Meegomäe Village, Võru County, 65526, Estonia
Dermatology Clinic of Tartu University Hospital
Tartu, 50417, Estonia
Psoriasis Study Center
Berlin, 10117, Germany
Dermatologische Praxis
Berlin, 10827, Germany
Klinische Forschung Berlin - Buch GmbH
Berlin, 13125, Germany
University Hospital Carl Gustav Carus
Dresden, 1307, Germany
Hautklinik Universitatsklinikum Erlangen
Erlangen, 91054, Germany
University Hospital Frankfurt
Frankfurt, 60590, Germany
SCIderm GmbH
Hamburg, 20354, Germany
Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center
Hamburg, D-20246, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69115, Germany
UniversitatsKlinikum Leipzig A.o.R.
Leipzig, 4103, Germany
Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein
Lübeck, 23538, Germany
Gemeinschaftspraxis Mahlow
Mahlow, 15831, Germany
University Hospital Munster
Münster, 48143, Germany
Praxis fr Dermatologie und Venerologie
Wuppertal, 42275, Germany
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Allergo-Derm Bakos Kft.
Szolnok, 5000, Hungary
LTD M & M centrs
Ādaži, 2164, Latvia
Arija's Ancane's Family Doctor Private Practice
Baldone, 2125, Latvia
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
Riga, 1001, Latvia
Adoria Ltd
Riga, 1011, Latvia
Family Doctor's Indra's Kenina's Practice
Riga, 1011, Latvia
Health Center of Talsi Ltd
Talsi, 3201, Latvia
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Radboud University Medical Centre
Nijmegen, 6500HB, Netherlands
University Hospital of Wales
Cardiff, CF14 4XN, United Kingdom
Leeds Teaching Hospitals Trust
Leeds, LS7 4SA, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
St Helier Hospital
London, SM5 1AA, United Kingdom
George Eliot Hospital
Nuneaton, CV10 7DJ, United Kingdom
Related Publications (3)
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.
PMID: 34255891BACKGROUNDMease 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.
PMID: 37316690DERIVEDReich 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.
PMID: 27768242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne McClain, Senior Manager, Clinical Trial Disclosure
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2012
First Posted
September 21, 2012
Study Start
October 1, 2012
Primary Completion
July 3, 2014
Study Completion
April 4, 2016
Last Updated
March 15, 2022
Results First Posted
August 4, 2015
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request