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Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Primary Purpose

Psoriasis, Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast

Etanercept

Placebo tablet

Placebo injection

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, arthritis, psoriatic, palmoplantar, scalp, psoriasis pill, psoriasis tablet, plaque psoriasis, plaque type psoriasis, moderate to severe plaque type psoriasis, psoriatic arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arizona Research Center
Bakersfield Dermatology and Skin Cancer Medical Group
University of California Irvine-Department of Dermatology
University of California San Diego Medical Center
Horizons Clinical Research
George Washington University
Florida Center for Dermatology, PA
Florida Academic Dermatology Center
International Dermatology Research
Renstar Medical Research
Atlanta Dermatology, Vein and Research Center, PC
NorthShore University HealthSystem
Southern Illinois University School of Medicine
Dawes Fretzin Clinical Research Group, LLC
Dermatology and Advanced Aesthetics
Lawrence Green, MD, LLC
Dartmouth Hitchcock Medical Center
Robert Wood Johnson Medical School
Forest Hills Dermatology Group
NYU Department of Dermatology
University of North Carolina
Duke University Medical Center
Wake Forest University Health Sciences
University Hospitals Case Medical Center
Ohio State University Medical Center
University of Pittsburgh Medical Center
Tennesse Clinical Research Center
Teckton Research
The Education and Research Foundation
Virginia Clinical Research Inc
Dermatology Associates of Seattle
The Skin Centre
Sinclair Dermatology
Fremantle Dermatology
Gairdner Hospital
Rheumatology unit Ward 5C Queen Elizabeth Hospital
Veracity Clinical Research
Cliniques Universitaires St-Luc
University Hospital Ghent
University Hospital of Liege CHU Liege
Eastern Canada Cutaneous Research Associates Ltd
Skin Center for Dermatology
K. Papp Clinical Research Inc.
Siena Medical Research
Q & T Research Sherbrooke Inc.
Dorothea, Kožní a korektivne dermatologické pracovište
Dermamedica
Východoceské dermatologické centrum Homea s.r.o.
Krajská nemocnice Pardubice, Kožní oddelení
Dermatovenerologicka ambulance
Koznia zilni ambulance
South Estonian Hospital Ltd
Dermatology Clinic of Tartu University Hospital
Psoriasis Study Center
Dermatologische Praxis
Klinische Forschung Berlin - Buch GmbH
University Hospital Carl Gustav Carus
Hautklinik Universitatsklinikum Erlangen
University Hospital Frankfurt
SCIderm GmbH
Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center
Universitatsklinikum Heidelberg
UniversitatsKlinikum Leipzig A.o.R.
Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein
Gemeinschaftspraxis Mahlow
University Hospital Munster
Praxis fr Dermatologie und Venerologie
Tolna Megyei Balassa Janos Korhaz
Allergo-Derm Bakos Kft.
LTD M & M centrs
Arija's Ancane's Family Doctor Private Practice
Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre
Adoria Ltd
Family Doctor's Indra's Kenina's Practice
Health Center of Talsi Ltd
Academic Medical Center
Radboud University Medical Centre
University Hospital of Wales
Leeds Teaching Hospitals Trust
Whipps Cross University Hospital
St Helier Hospital
George Eliot Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast 30 mg plus placebo injection

Etanercept 50 mg plus placebo tablet

Oral placebo tablets plus SC placebo injections

Arm Description

Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections

Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID

Identically matching placebo tablets and evaluator/subject-blinded SC injections

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Psoriasis Flare/Rebound

Full Information

NCT ID

NCT01690299

First Posted

September 19, 2012

Last Updated

March 3, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01690299

Brief Title

Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2012 (Actual)

Primary Completion Date

July 3, 2014 (Actual)

Study Completion Date

April 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Psoriatic Arthritis

Keywords

Psoriasis, arthritis, psoriatic, palmoplantar, scalp, psoriasis pill, psoriasis tablet, plaque psoriasis, plaque type psoriasis, moderate to severe plaque type psoriasis, psoriatic arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast 30 mg plus placebo injection

Arm Type

Experimental

Arm Description

Apremilast 30 mg tablets orally twice a day (BID) plus once weekly (QW) evaluator/subject-blinded subcutaneous (SC) saline (placebo) injections

Arm Title

Etanercept 50 mg plus placebo tablet

Arm Type

Experimental

Arm Description

Etanercept 50 mg evaluator/subject-blinded SC QW injections plus placebo tablets orally BID

Arm Title

Oral placebo tablets plus SC placebo injections

Arm Type

Placebo Comparator

Arm Description

Identically matching placebo tablets and evaluator/subject-blinded SC injections

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

CC-10004, Otezla

Intervention Description

Apremilast 30 mg tablet orally BID

Intervention Type

Drug

Intervention Name(s)

Etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

Etanercept 50 mg evaluator/subject-blinded SC QW injection

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Intervention Description

Placebo tablets BID

Intervention Type

Drug

Intervention Name(s)

Placebo injection

Intervention Description

Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and Week 16

Title

Description

Time Frame

Baseline and Week 16

Title

Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

Description

Time Frame

Baseline to Week 16

Title

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

Description

Time Frame

Baseline to Week 16

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16

Description

Time Frame

Baseline to Week 16

Title

Description

Time Frame

Baseline to Week 16

Title

Description

Time Frame

Baseline to Week 16

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase

Description

Time Frame

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

Title

Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period

Description

Time Frame

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

Title

Psoriasis Flare/Rebound

Description

Time Frame

Week 0 to Week 16; Placebo controlled phase

Title

Psoriasis Flare/Rebound

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Bakersfield Dermatology and Skin Cancer Medical Group

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

University of California Irvine-Department of Dermatology

City

Irvine

State/Province

California

ZIP/Postal Code

92697

Country

United States

Facility Name

University of California San Diego Medical Center

City

San Diego

State/Province

California

ZIP/Postal Code

92122

Country

United States

Facility Name

Horizons Clinical Research

City

Denver

State/Province

Colorado

ZIP/Postal Code

80220

Country

United States

Facility Name

George Washington University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Florida Center for Dermatology, PA

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Florida Academic Dermatology Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

International Dermatology Research

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Atlanta Dermatology, Vein and Research Center, PC

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30022

Country

United States

Facility Name

NorthShore University HealthSystem

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Southern Illinois University School of Medicine

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Dermatology and Advanced Aesthetics

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70605

Country

United States

Facility Name

Lawrence Green, MD, LLC

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Robert Wood Johnson Medical School

City

Somerset

State/Province

New Jersey

ZIP/Postal Code

08873

Country

United States

Facility Name

Forest Hills Dermatology Group

City

Forest Hills

State/Province

New York

ZIP/Postal Code

11375

Country

United States

Facility Name

NYU Department of Dermatology

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27516

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

University Hospitals Case Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43230

Country

United States

Facility Name

University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Tennesse Clinical Research Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Teckton Research

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

The Education and Research Foundation

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Virginia Clinical Research Inc

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Dermatology Associates of Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

The Skin Centre

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

Facility Name

Sinclair Dermatology

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Fremantle Dermatology

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

Gairdner Hospital

City

Victoria Park

ZIP/Postal Code

6100

Country

Australia

Facility Name

Rheumatology unit Ward 5C Queen Elizabeth Hospital

City

Woodville

ZIP/Postal Code

5011

Country

Australia

Facility Name

Veracity Clinical Research

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Cliniques Universitaires St-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

University Hospital Ghent

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

University Hospital of Liege CHU Liege

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Eastern Canada Cutaneous Research Associates Ltd

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1Z4

Country

Canada

Facility Name

Skin Center for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

K. Papp Clinical Research Inc.

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Siena Medical Research

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3Z 2S6

Country

Canada

Facility Name

Q & T Research Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 4J6

Country

Canada

Facility Name

Dorothea, Kožní a korektivne dermatologické pracovište

City

Chomutov

ZIP/Postal Code

430 04

Country

Czechia

Facility Name

Dermamedica

City

Nachod

ZIP/Postal Code

54701

Country

Czechia

Facility Name

Východoceské dermatologické centrum Homea s.r.o.

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Krajská nemocnice Pardubice, Kožní oddelení

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Dermatovenerologicka ambulance

City

Svitavy

ZIP/Postal Code

568 02

Country

Czechia

Facility Name

Koznia zilni ambulance

City

Ústí nad Labem

ZIP/Postal Code

400 10

Country

Czechia

Facility Name

South Estonian Hospital Ltd

City

Meegomäe Village, Võru County

ZIP/Postal Code

65526

Country

Estonia

Facility Name

Dermatology Clinic of Tartu University Hospital

City

Tartu

ZIP/Postal Code

50417

Country

Estonia

Facility Name

Psoriasis Study Center

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Dermatologische Praxis

City

Berlin

ZIP/Postal Code

10827

Country

Germany

Facility Name

Klinische Forschung Berlin - Buch GmbH

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

University Hospital Carl Gustav Carus

City

Dresden

ZIP/Postal Code

1307

Country

Germany

Facility Name

Hautklinik Universitatsklinikum Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

University Hospital Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

SCIderm GmbH

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Institute for Health Services Research in Dermatology and Nursing - IVDP, University Medical Center

City

Hamburg

ZIP/Postal Code

D-20246

Country

Germany

Facility Name

Universitatsklinikum Heidelberg

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

UniversitatsKlinikum Leipzig A.o.R.

City

Leipzig

ZIP/Postal Code

4103

Country

Germany

Facility Name

Comprehensive Center of Inflammatory Medicine (CCIM) University Medical Center Schleswig-Holstein

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Gemeinschaftspraxis Mahlow

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

University Hospital Munster

City

Münster

ZIP/Postal Code

48143

Country

Germany

Facility Name

Praxis fr Dermatologie und Venerologie

City

Wuppertal

ZIP/Postal Code

42275

Country

Germany

Facility Name

Tolna Megyei Balassa Janos Korhaz

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Allergo-Derm Bakos Kft.

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

LTD M & M centrs

City

Adazi

ZIP/Postal Code

2164

Country

Latvia

Facility Name

Arija's Ancane's Family Doctor Private Practice

City

Baldone

ZIP/Postal Code

2125

Country

Latvia

Facility Name

Riga 1st Hospital Skin and Sexually Transmitted Diseases Clinical Centre

City

Riga

ZIP/Postal Code

1001

Country

Latvia

Facility Name

Adoria Ltd

City

Riga

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Family Doctor's Indra's Kenina's Practice

City

Riga

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Health Center of Talsi Ltd

City

Talsi

ZIP/Postal Code

3201

Country

Latvia

Facility Name

Academic Medical Center

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Radboud University Medical Centre

City

Nijmegen

ZIP/Postal Code

6500HB

Country

Netherlands

Facility Name

University Hospital of Wales

City

Cardiff

ZIP/Postal Code

CF14 4XN

Country

United Kingdom

Facility Name

Leeds Teaching Hospitals Trust

City

Leeds

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Whipps Cross University Hospital

City

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

St Helier Hospital

City

London

ZIP/Postal Code

SM5 1AA

Country

United Kingdom

Facility Name

George Eliot Hospital

City

Nuneaton

ZIP/Postal Code

CV10 7DJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://www.amgen.com/datasharing

Citations:

PubMed Identifier

34255891

Citation

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.

Results Reference

background

PubMed Identifier

27768242

Citation

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.

Results Reference

derived

Learn more about this trial

Phase 3b Safety and Efficacy Study of Apremilast to Treat Moderate to Severe Plaque-plaque Psoriasis

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