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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Drug: Apremilast; Drug: Placebo injection; Drug: Etanercept; Drug: Placebo tablet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Victoria Park, Australia, 6100
    • Gairdner Hospital
  • Woodville, Australia, 5011
    • Rheumatology unit Ward 5C Queen Elizabeth Hospital
  • Woolloongabba, Australia, 4102
    • Veracity Clinical Research
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Ghent, Belgium, 9000
    • University Hospital Ghent
  • Liege, Belgium, 4000
    • University Hospital of Liege CHU Liege
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z4
      • Eastern Canada Cutaneous Research Associates Ltd
  • Ontario
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Center for Dermatology
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H3Z 2S6
      • Siena Medical Research
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • Q & T Research Sherbrooke Inc.
• Czechia
  • Chomutov, Czechia, 430 04
    • Dorothea, Kožní a korektivne dermatologické pracovište
  • Nachod, Czechia, 54701
    • Dermamedica
  • Pardubice, Czechia, 530 02
    • Východoceské dermatologické centrum Homea s.r.o.
  • Pardubice, Czechia, 532 03
    • Krajská nemocnice Pardubice, Kožní oddelení
  • Svitavy, Czechia, 568 02
    • Dermatovenerologicka ambulance
  • Ústí nad Labem, Czechia, 400 10
    • Koznia zilni ambulance
• Estonia
  • Meegomäe Village, Võru County, Estonia, 65526
    • South Estonian Hospital Ltd
  • Tartu, Estonia, 50417
    • Dermatology Clinic of Tartu University Hospital
• Germany
  • Berlin, Germany, 13125
    • Klinische Forschung Berlin - Buch GmbH
  • Berlin, Germany, 10117
    • Psoriasis Study Center
  • Berlin, Germany, 10827
    • Dermatologische Praxis
  • Dresden, Germany, 1307
    • University Hospital Carl Gustav Carus
  • Erlangen, Germany, 91054
    • Hautklinik Universitatsklinikum Erlangen
  • Frankfurt, Germany, 60590
    • University Hospital Frankfurt
  • Hamburg, Germany, 20354
    • SCIderm GmbH
  • Hamburg, Germany, D-20246
    • Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center
  • Heidelberg, Germany, 69115
    • UniversitatsKlinikum Heidelberg
  • Leipzig, Germany, 4103
    • UniversitatsKlinikum Leipzig A.o.R.
  • Lübeck, Germany, 23538
    • Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein
  • Mahlow, Germany, 15831
    • Gemeinschaftspraxis Mahlow
  • Münster, Germany, 48143
    • University Hospital Münster
  • Wuppertal, Germany, 42275
    • Praxis fr Dermatologie und Venerologie
• Hungary
  • Szekszárd, Hungary, 7100
    • Tolna Megyei Balassa Janos Korhaz
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft.
• Latvia
  • Adazi, Latvia, 2164
    • LTD M & M centrs
  • Baldone, Latvia, 2125
    • Arija's Ancane's Family Doctor Private Practice
  • Riga, Latvia, 1001
    • Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
  • Riga, Latvia, 1011
    • Adoria Ltd
  • Riga, Latvia, 1011
    • Family Doctor's Indra's Kenina's Practice
  • Talsi, Latvia, 3201
    • Health Center of Talsi Ltd
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center
  • Nijmegen, Netherlands, 6500HB
    • Radboud University Medical Centre
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XN
    • University Hospital of Wales
  • Leeds, United Kingdom, LS7 4SA
    • Leeds Teaching Hospitals Trust
  • London, United Kingdom, E11 1NR
    • Whipps Cross University Hospital
  • London, United Kingdom, SM5 1AA
    • St Helier Hospital
  • Nuneaton, United Kingdom, CV10 7DJ
    • George Eliot Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Dermatology and Skin Cancer Medical Group
    • Irvine, California, United States, 92697
      • University of California Irvine-Department of Dermatology
    • San Diego, California, United States, 92122
      • University of California San Diego Medical Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Florida Center for Dermatology, PA
    • Miami, Florida, United States, 33144
      • International Dermatology Research
    • Miami, Florida, United States, 33136
      • Florida Academic Dermatology Center
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein and Research Center, PC
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Northshore University Healthsystem
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Dermatology and Advanced Aesthetics
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence Green, MD, LLC
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Robert Wood Johnson Medical School
  • New York
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • New York, New York, United States, 10016
      • NYU Department of Dermatology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University Health Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43230
      • Ohio State University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennesse Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78745
      • Teckton Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research Inc
  • Washington
    • Seattle, Washington, United States, 98101
      • Dermatology Associates of Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Apremilast; Apremilast 30 mg tablet orally BID; Other Names: CC-10004; Otezla; Drug: Placebo injection; Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
Experimental: Etanercept 50 mg plus placebo tablet; Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID	Drug: Etanercept; Etanercept 50 mg evaluator/subject-blinded SC QW injection; Other Names: Enbrel; Drug: Placebo tablet; Placebo tablets BID
Placebo Comparator: Oral placebo tablets plus SC placebo injections; Identically matching placebo tablets and evaluator/subject-blinded SC injections	Drug: Placebo injection; Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC); Drug: Placebo tablet; Placebo tablets BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 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	The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.	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	BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA.	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	PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score 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
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16	DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.	Baseline to Week 16
Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16	The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value - baseline value.	Baseline to Week 16
Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16	The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.	Baseline to Week 16
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase	A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.	Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group
Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period	A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.	From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose
Psoriasis Flare/Rebound	Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.	Week 0 to Week 16; Placebo controlled phase
Psoriasis Flare/Rebound	Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.	From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): July 3, 2014
• Study Completion (Actual): April 4, 2016

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Psoriasis; psoriatic arthritis; arthritis; plaque psoriasis; plaque type psoriasis; scalp; palmoplantar; psoriatic; psoriasis pill; psoriasis tablet; moderate to severe plaque type psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Etanercept; Apremilast
• Other Study ID Numbers: CC-10004-PSOR-010; 2012-000859-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR