Back to resultsApremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (ADVANCE)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Phase 3, Double-Blind, Efficacy, Safety, Apremilast, Otezla, CC-10004, Plaque Psoriasis, Mild, Moderate, Scalp, Nail, Itch
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
- Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
- Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
- Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
- Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
- Subject must meet laboratory criteria.
- Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subjects has 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.
2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
9. Subject had prior treatment with apremilast.
Sites / Locations
- Total Skin & Beauty Dermatology Center
- Johnson Dermatology Clinic
- Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
- Dermatology Research Associates
- TCR Medical Corporation
- University of California San Francisco Psoriasis and Skin Treatment Center
- Clinical Science Institute
- University of Colorado Hospital - Dermatology Clinic
- Total Vein and Skin, LLC
- Florida Academic Centers Research and Education
- International Dermatology Research
- Center for Clinical and Cosmetic Research
- Renstar Medical Research
- University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
- Atlanta Dermatology, Vein and Research Center, PC
- Medical Dermatology Specialists, Inc. - Advanced Medical Research
- MedaPhase INC
- Gwinnett Clinical Research Center, Inc.
- Dawes Fretzin Clinical Research Group, LLC
- Clinical Trials Management LLC
- Derm Associates
- Lawrence Green, MD, LLC
- ActivMed Practices & Research Inc
- Massachusetts General Hospital
- Henry Ford Medical Center - New Center One
- Minnesota Clinical Study Center
- Central Dermatology
- JDR Dermatology Research, LLC
- Psoriasis Treatment Center of Central New Jersey
- Albert Einstein College of Medicine - Montefiore Medical Center
- Icahn School of Medicine at Mount Sinai
- Wake Forest University Health Sciences
- Ohio State University Wexner Medical Center
- Wright State Physicians
- Temple University - Lewis Katz School of Medicine
- University of Pittsburgh Medical Center
- Clinical Partners, LLC
- Clinical Research Center of the Carolinas
- Austin Institute for Clinical Research
- Center for Clinical Studies
- University of Utah MidValley Dermatology
- Virginia Clinical Research Inc
- Dermatology Center for Skin Health
- Institute for Skin Advancement
- Stratica Medical
- Chih-Ho Hong Medical, Inc.
- Enverus Medical Research
- Winnipeg Clinic Dermatology Research
- SkinWise Dermatology
- Brunswick Dermatology Centre
- Karma Clinical Trials
- SimcoDerm Medical and Surgical Dermatology Center
- Guelph Dermatology Research
- DermEffects
- Lynderm Research
- North Bay Dermatology Centre
- Skin Center for Dermatology
- Toronto Research Centre
- Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor
- K. Papp Clinical Research
- Windsor Clinical Research Inc.
- Dr Isabelle Delorme inc
- Dre Angelique Gagne-Henley M.D. Inc.
- Skinsense Medical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Placebo-controlled Phase:
Placebo-controlled Phase: Apremilast 30 mg
Extension Phase: Apremilast 30 mg
Arm Description
Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
Outcomes
Primary Outcome Measures
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.
Secondary Outcome Measures
Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Change From Baseline in Percentage of Affected BSA at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
A negative change from baseline indicates a reduction of affected BSA.
Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16
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. 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.
PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
A negative change from baseline indicates an improvement of disease symptoms.
Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4
The whole body itch NRS is a self-reported measure where participants were asked to assess whole body itch and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. A reduction in score from baseline represents an improvement in symptoms.
Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16
The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an Investigator's assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation of the overall scalp.
An ScPGA response is defined as and ScPGA score clear (0) or almost clear (1) with at least a 2-point reduction from baseline among participants with a baseline ScPGA score ≥ 2.
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). 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), 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 0 (not at all), 1 (a little) and 2 (a lot).
Total scores have a possible range of 0 to 30, with 30 corresponding to the worst health-related quality of life, and 0 corresponding to the best score.
A negative change from baseline indicates an improvement in health-related quality of life scores.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A TEAE is any AE that occurs following administration of study treatment.
Frequency of TEAEs was assessed as well as severity and treatment relatedness.
A TEAE was considered severe based on the Investigator's assessment. A TEAE could be severe if it was serious or non-serious, had symptoms causing discomfort or pain, requiring medical or surgical attention or intervention, interfered with activities of daily life and if drug therapy was required.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03721172
Brief Title
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
Acronym
ADVANCE
Official Title
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
July 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.
Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.
Detailed Description
The study will consist of four phases:
Screening Phase - up to 35 days
Double-blind Placebo-controlled Phase - Weeks 0 to 16
- Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.
Apremilast Extension Phase - Weeks 16 to 32
- All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.
Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Phase 3, Double-Blind, Efficacy, Safety, Apremilast, Otezla, CC-10004, Plaque Psoriasis, Mild, Moderate, Scalp, Nail, Itch
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
595 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo-controlled Phase:
Arm Type
Experimental
Arm Description
Participants received placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16).
Arm Title
Placebo-controlled Phase: Apremilast 30 mg
Arm Type
Experimental
Arm Description
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16).
Arm Title
Extension Phase: Apremilast 30 mg
Arm Type
Experimental
Arm Description
Eligible participants who completed the placebocontrolled phase entered the extension phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
Intervention Type
Drug
Intervention Name(s)
Apremilast
Intervention Description
Apremilast, oral, twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral, twice daily
Primary Outcome Measure Information:
Title
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 During the Placebo-Controlled Phase
Description
The sPGA is a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 =severe. Scores incorporate an assessment by the Investigator of the severity of the 3 primary signs of the disease: erythema, scaling and plaque elevation.
An sPGA response is defined as sPGA score of clear (0) or almost clear (1) and with at least a 2-point reduction from baseline at Week 16.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Secondary Outcome Measure Information:
Title
Percentage of Participants With a ≥ 75 Percent (%) Improvement From Baseline in Affected Body Surface Area (BSA) at Week 16
Description
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Change From Baseline in Percentage of Affected BSA at Week 16
Description
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
A negative change from baseline indicates a reduction of affected BSA.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Change From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 16
Description
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. 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.
PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
A negative change from baseline indicates an improvement of disease symptoms.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Percentage of Participants Who Achieved BSA ≤ 3% for Participants With Baseline Affected BSA > 3% at Week 16
Description
The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand. The surface area of the whole body is made up of approximately 100 palms or "handprints" (each entire palmar surface or "handprint" equates to approximately 1% of total body surface area).
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Percentage of Participants With ≥ 4-point Reduction From Baseline in Whole Body Itch Numeric Rating Scale (NRS) Score at Week 16 Who Had Baseline Whole Body Itch NRS ≥ 4
Description
The whole body itch NRS is a self-reported measure where participants were asked to assess whole body itch and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch. A reduction in score from baseline represents an improvement in symptoms.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Percentage of Participants With a Scalp Physician Global Assessment (ScPGA) Response at Week 16 Among Participants With Baseline scPGA Score ≥ 2 at Week 16
Description
The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an Investigator's assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation of the overall scalp.
An ScPGA response is defined as and ScPGA score clear (0) or almost clear (1) with at least a 2-point reduction from baseline among participants with a baseline ScPGA score ≥ 2.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16
Description
The DLQI is a 10 item questionnaire dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from 0 (not at all) to 3 (very much). 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), 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 0 (not at all), 1 (a little) and 2 (a lot).
Total scores have a possible range of 0 to 30, with 30 corresponding to the worst health-related quality of life, and 0 corresponding to the best score.
A negative change from baseline indicates an improvement in health-related quality of life scores.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A TEAE is any AE that occurs following administration of study treatment.
Frequency of TEAEs was assessed as well as severity and treatment relatedness.
A TEAE was considered severe based on the Investigator's assessment. A TEAE could be severe if it was serious or non-serious, had symptoms causing discomfort or pain, requiring medical or surgical attention or intervention, interfered with activities of daily life and if drug therapy was required.
Time Frame
Placebo: Day 1 to Week 16; Apremilast Day 1 to a maximum of Week 32 (plus 4 week safety follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
Subject must meet laboratory criteria.
Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Subjects has 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.
2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.
4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).
5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.
6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.
8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
9. Subject had prior treatment with apremilast.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin & Beauty Dermatology Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Johnson Dermatology Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
TCR Medical Corporation
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco Psoriasis and Skin Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Colorado Hospital - Dermatology Clinic
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Total Vein and Skin, LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Florida Academic Centers Research and Education
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Center for Clinical and Cosmetic Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
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
Medical Dermatology Specialists, Inc. - Advanced Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
MedaPhase INC
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Gwinnett Clinical Research Center, Inc.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
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
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Derm Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Lawrence Green, MD, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
ActivMed Practices & Research Inc
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2517
Country
United States
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Central Dermatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
JDR Dermatology Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Albert Einstein College of Medicine - Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
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
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Temple University - Lewis Katz School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Partners, LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Clinical Research Center of the Carolinas
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University of Utah MidValley Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Clinical Research Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Dermatology Center for Skin Health
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Institute for Skin Advancement
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3A 2N1
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Chih-Ho Hong Medical, Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
Winnipeg Clinic Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3CON2
Country
Canada
Facility Name
SkinWise Dermatology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Brunswick Dermatology Centre
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 1G9
Country
Canada
Facility Name
Karma Clinical Trials
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
SimcoDerm Medical and Surgical Dermatology Center
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Guelph Dermatology Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1L 0B7
Country
Canada
Facility Name
DermEffects
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada
Facility Name
Lynderm Research
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
North Bay Dermatology Centre
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Skin Center for Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Toronto Research Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Sameh Hanna Medicine Professional Corporation DBA Dermatology on Bloor
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N2
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research Inc.
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Dr Isabelle Delorme inc
City
Drummondville
State/Province
Quebec
ZIP/Postal Code
J2B 5L4
Country
Canada
Facility Name
Dre Angelique Gagne-Henley M.D. Inc.
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 7E2
Country
Canada
Facility Name
Skinsense Medical Research
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
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
34343599
Citation
Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy
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