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Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis. (ESTEEM 2)

Primary Purpose

Plaque Psoriasis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Apremilast

Placebo

Topical or Phototherapy Therapy

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

Males or females, ≥ 18 years of age at the time of signing the informed consent document
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
a. Have moderate to severe plaque psoriasis at Screening and Baseline
Must meet all laboratory criteria
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.

Exclusion Criteria:

Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Pregnant or breast feeding
History of allergy to any component of the study drug
Hepatitis B surface antigen positive at Screening
Anti-hepatitis C antibody positive at Screening
Active tuberculosis (TB) or a history of incompletely treated TB
Clinically significant abnormality on 12-Lead ECG at Screening
Clinically significant abnormal chest x-ray
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] 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
Evidence of skin conditions that would interfere with clinical assessments
Topical therapy within 2 weeks of randomization
Systemic therapy for psoriasis within 4 weeks prior to randomization
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Use of any investigational drug within 4 weeks prior to randomization
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Prior treatment with apremilast

Sites / Locations

Arizona Skin and Laser Therapy Inst., Ltd.
Burke Pharmaceutical Research
Bakersfield Dermatology and Skin Cancer Medical Group
Dermatology Research Associates
Clinical Science Institute
Florida Academic Dermatology Center
Advanced Medical Research
MedaPhase Inc.
Northwestern University Northwestern Medical Faculty Foundation
Tufts Medical Center
PMG Research of Winston-Salem
Wake Forest University Health Sciences
Clinical Partners, LLC
Radiant Research, Inc.
Austin Dermatology Associates
Modern Research Associates PLLC
Center for Clinical Studies
Center for Clinical Studies
Virginia Medical Research
Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie
Northwest Dermatology and Laser Centre
Stratica Medical
NewLab Clinical Research
Skin Center for Dermatology
Windsor Clinical Research Inc.
Q & T Research Sherbrooke Inc.
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
Bispebjerg Hospital
Centre d'lnvestigation Clinique, Hopital Jean Minjoz
Hospital haut leveque
Larrey University Hospital
Dr. med. Beatrice Gerlach
Universitatsklinikum Hamburg-Eppendorf / IVDP
Universitäts-Hautklinik Kiel
Universitatsklinikum Leipzig
Hautarztpraxis Mahlow
Universita degli Studi di Napoli Federico II
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia
Hospital Universitario Fundacion Alcorcon
Hospital Universitari Germans Trias i Pujol
Hospital Abente y Lago
Hospital Universitario La Princesa
Hospital Universitario 12 de Octubre
Hopitaux Universitaires de Geneve-HUG
University of Zurich Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apremilast

Placebo

Arm Description

Participants were initially randomized 2:1 and received apremilast 30 mg twice a day (BID). Participants maintained dosing through Week 32. At Week 32, responders, those with a Psoriasis Area Severity Index response -≥75 (PASI-75) and partial responders (≥PASI-50) were re-randomized 1:1 to apremilast 30 mg BID or matching placebo (treatment withdrawal). Participants could resume apremilast 30 mg BID at the time of loss of 50% of improvement in PASI score response which was observed at Week 32 compared to baseline), and no later than Week 52. At Week 52, the non-responders (<PASI-50) had the option of adding topical therapies and/or phototherapy to their treatment regimen. Those re-randomized to apremilast 30 mg BID continued dosing through Week 52. At Week 52, participants continued treatment with apremilast 30 mg BID.

Participants will be initially randomized to placebo, identically matching during Weeks 0-16. At Week 16, Placebo participants will be switched to receive apremilast 30 mg BID. All participants will maintain Apremilast dosing through Week 32. At Week 32, participants originally randomized to placebo at baseline (Week 0) and are considered non-responders i( < PASI-50) will have the option of adding topical therapies and/or phototherapy to their Apremilast treatment regimen. At Week 52, all participants will continue treatment with apremilast 30 mg BID. Participants will be followed and evaluated for safety and efficacy for up to an additional 4 years (years 2 through 5).

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) 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 is 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 is missing.

Secondary Outcome Measures

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 From Baseline

The sPGA was a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 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 must have factored 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 was 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) at Week 16

BSA was 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 (Visit 2 Week 0) was determined at each visit of the study, which is calculated as 100*(visit BSA - baseline BSA) / baseline BSA (%).

Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16

Psoriasis Area Severity Index (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 total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. The PASI score was set to missing if any severity score or degree of involvement is missing.

Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline

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 improvement in PASI score was used as a measure of efficacy. The PASI is 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 is missing.

Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16

The Pruritus Visual Analog Scores (VAS) were used to measure the amount of itching and discomfort a participant experiences. Participant's Assessment of Pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? All VAS values range from 0 to 100. Higher scores correspond to more severe symptom or disease. Change from baseline was calculated for the VAS scale, where change = visit value - baseline value.

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score 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 subject 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 was 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 (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16

The SF-36 was a 36-item general health 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. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.

Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction 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. See Outcome measure #1 for further description. sPGA is a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. See Outcome Measure #2 for further description.

Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase

Time to loss was the time between the re-randomization date and the date of the first assessment with loss of 50% PASI improvement (event), or the time between the re-randomization date and the date of the last PASI assessment in the randomized withdrawal phase prior to addition of topical/phototherapy or other effective psoriasis therapies, or resumption of apremilast 30 mg BID, or discontinuation, or Week 52 if no loss (censored), whichever was earlier

Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase

An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant'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) was considered an AE. A serious AE (SAE) is any untoward adverse event 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 the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase

Psoriasis flare was defined as a sudden intensification of psoriasis requiring medical intervention, or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. Note categories below. [1] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis) started on or after the first dose date and on or before the last dose date within the phase. [2] Psoriasis adverse events (ie, preferred term as Guttate psoriasis, Psoriasis, Pustular psoriasis, Rebound psoriasis) started after the last dose date for participants who discontinued within the phase. [3] PASI >= 125% of baseline score at any visit after the last dose date for participants who discontinued within the phase and were not included in [1] and/or [2].

Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260

The Apremilast-exposure Period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. Adverse events that started after 28 days of initiating placebo and before resuming apremilast treatment in the Randomized Treatment Withdrawal Phase (Weeks 32 to 52) were excluded in the Apremilast-exposure phase. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period

Full Information

NCT ID

NCT01232283

First Posted

October 29, 2010

Last Updated

March 3, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01232283

Brief Title

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

Acronym

ESTEEM 2

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) 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

November 22, 2010 (Actual)

Primary Completion Date

March 15, 2012 (Actual)

Study Completion Date

November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

6. Conditions and Keywords

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

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apremilast

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Apremilast

Other Intervention Name(s)

CC-10004, Otezla

Intervention Description

Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.

Intervention Type

Other

Intervention Name(s)

Topical or Phototherapy Therapy

Intervention Description

Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) at Week 16 From Baseline

Description

Time Frame

Baseline to Week 16

Secondary Outcome Measure Information:

Title

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 From Baseline

Description

Time Frame

Baseline to Week 16

Title

Percent Change From Baseline in the Affected Body Surface Area (BSA) at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percent Change From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score (PASI-50) at Week 16 From Baseline

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Pruritus Visual Analog Scale (VAS) Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change From Baseline in the Mental Component Summary (MSC) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16

Description

Time Frame

Baseline to Week 16

Title

Percentage of Participants Who Achieved Both a 75% Improvement (Response) in the PASI and sPGA Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction at Week 16 From Baseline

Description

Time Frame

Baseline to Week 16

Title

Time to Loss of Effect (Loss of 50% Improvement in PASI Score Obtained at Week 32 Compared to Baseline) During the Randomized Treatment Withdrawal Phase

Description

Time Frame

Weeks 32 to Week 52

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Placebo Controlled Phase

Description

Time Frame

Baseline to Week 16

Title

Number of Participants With Psoriasis Flare or Rebound in the Placebo Controlled Phase

Description

Time Frame

Week 0 to Week 16

Title

Number of Participants With TEAEs During the Apremilast-Exposure Period Through Week 260

Description

Time Frame

Week 0 to Week 260; The mean duration of exposure was 100.66 weeks.

Title

Number of Participants With Psoriasis Flare or Rebound in the Apremilast-Exposure Period

Description

Time Frame

Week 0 to Week 260

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 at the time of signing the informed consent document Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening a. Have moderate to severe plaque psoriasis at Screening and Baseline Must meet all laboratory criteria Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication. Exclusion Criteria: Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease. Pregnant or breast feeding History of allergy to any component of the study drug Hepatitis B surface antigen positive at Screening Anti-hepatitis C antibody positive at Screening Active tuberculosis (TB) or a history of incompletely treated TB Clinically significant abnormality on 12-Lead ECG at Screening Clinically significant abnormal chest x-ray History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency Active substance abuse or a history of substance abuse within 6 months prior to Screening Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] 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 Evidence of skin conditions that would interfere with clinical assessments Topical therapy within 2 weeks of randomization Systemic therapy for psoriasis within 4 weeks prior to randomization Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA) Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization Use of any investigational drug within 4 weeks prior to randomization Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources Prior treatment with apremilast

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Skin and Laser Therapy Inst., Ltd.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Burke Pharmaceutical Research

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

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

Dermatology Research Associates

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Clinical Science Institute

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Florida Academic Dermatology Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Advanced Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

MedaPhase Inc.

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

Northwestern University Northwestern Medical Faculty Foundation

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

PMG Research of Winston-Salem

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

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

Clinical Partners, LLC

City

Johnston

State/Province

Rhode Island

ZIP/Postal Code

02919

Country

United States

Facility Name

Radiant Research, Inc.

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29560

Country

United States

Facility Name

Austin Dermatology Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

Facility Name

Modern Research Associates PLLC

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Clinical Studies

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Center for Clinical Studies

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Virginia Medical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Facility Name

Northwest Dermatology and Laser Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3G 0B4

Country

Canada

Facility Name

Stratica Medical

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5K 1X3

Country

Canada

Facility Name

NewLab Clinical Research

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 2H5

Country

Canada

Facility Name

Skin Center for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

Windsor Clinical Research Inc.

City

Winsor

State/Province

Ontario

ZIP/Postal Code

N8W 5L7

Country

Canada

Facility Name

Q & T Research Sherbrooke Inc.

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 4J6

Country

Canada

Facility Name

Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

City

Quebec

ZIP/Postal Code

G1V 4X7

Country

Canada

Facility Name

Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Centre d'lnvestigation Clinique, Hopital Jean Minjoz

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Hospital haut leveque

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Larrey University Hospital

City

Toulouse

ZIP/Postal Code

31000

Country

France

Facility Name

Dr. med. Beatrice Gerlach

City

Dresden

ZIP/Postal Code

01097

Country

Germany

Facility Name

Universitatsklinikum Hamburg-Eppendorf / IVDP

City

Hamburg

ZIP/Postal Code

D-20246

Country

Germany

Facility Name

Universitäts-Hautklinik Kiel

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitatsklinikum Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Hautarztpraxis Mahlow

City

Mahlow

ZIP/Postal Code

15831

Country

Germany

Facility Name

Universita degli Studi di Napoli Federico II

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

City

Rome

ZIP/Postal Code

00144

Country

Italy

Facility Name

A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Hospital Universitario Fundacion Alcorcon

City

Alcorcón

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona (Barcelona)

ZIP/Postal Code

8916

Country

Spain

Facility Name

Hospital Abente y Lago

City

La Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitario La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hopitaux Universitaires de Geneve-HUG

City

Geneva

ZIP/Postal Code

1205

Country

Switzerland

Facility Name

University of Zurich Hospital

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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

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Learn more about this trial

Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe Plaque Psoriasis.

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