Back to resultsAn Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (DISCREET)
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 Genital Psoriasis, CC-10004, Apremilast, Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 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 moderate or severe psoriasis of the genital area at Screening and Baseline.
- Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline.
- Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline.
- Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area.
- 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
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
- Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- Subject has prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- Subject has current or planned therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial
- Subject had prior treatment with apremilast.
Sites / Locations
- University of Alabama at Birmingham
- First OC Dermatology
- Clinical Science Institute
- Glick Skin Institute
- International Dermatology Research, Inc
- Skin Care Physicians of Georgia
- Dawes Fretzin Clinical Research Group, LLC
- Adult and Pediatric Dermatology
- ActivMed Practices and Research Inc
- Brigham and Womens Hospital
- J Woodson Dermatology and Associates
- Las Vegas Dermatology
- Dartmouth Hitchcock Medical Center
- ActivMed
- Stony Brook Dermatology Associates
- Dermatology Consulting Services
- Oakview Dermatology
- Ohio State University Medical Center
- Oregon Health and Science University
- Paddington Testing Company Inc
- Clinical Partners LLC
- Center for Clinical Studies
- Austin Institute for Clinical Research
- Virginia Clinical Research Inc
- Bellevue Dermatology Clinic
- Dermatology Center for Skin Health
- Centre Hospitalier Universitaire Saint Pierre
- Cliniques Universitaires St Luc
- UZ Leuven
- Guenther Dermatology Research Centre
- Lynderm Research Inc
- K Papp Clinical Research
- Dre Angelique Gagne-Henley M.D. Inc
- Skincare Studio
- Hopital Claude Huriez CHRU Lille
- CHU de Nice Archet I
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
- Larrey University Hospital
- ISA - Interdisciplinary Study Association GmbH
- Universitaetsklinikum Bonn
- Hautklinik Universitatsklinikum Erlangen
- Universitatsklinikum Frankfurt
- Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Ospedali Riuniti di Ancona
- Presidio Ospedaliero della Misericordia
- Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore
- Azienda Ospedaliera Di Padova
- Azienda Ospedaliera Bianchi Melacrino Morelli
- Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina
- Azienda Sanitaria Universitaria Integrata di Trieste
- GCM Medical Group, PSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A- Apremilast with Placebo
Arm B - Apremilast 30 mg
Arm Description
Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study
Outcomes
Primary Outcome Measures
Percentage of Participants With a Modified sPGA-G Response at Week 16
The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.
Secondary Outcome Measures
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
The sPGA is the 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), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment 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 ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16
The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
Change 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 BSA).
A negative change from Baseline indicates a reduction of affected BSA.
Based on mixed-effect model for repeated measures (MMRM) model.
Change From Baseline in Dermatology Life Quality Index (DLQI) 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 participant 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 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.
A negative change from Baseline indicates an improvement in health-related quality of life scores.
Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03777436
Brief Title
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Acronym
DISCREET
Official Title
A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
February 9, 2022 (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 Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe).
Approximately 286 subjects with moderate to severe genital 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
Genital Psoriasis, CC-10004, Apremilast, Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A- Apremilast with Placebo
Arm Type
Experimental
Arm Description
Subjects randomized to the apremilast 30 mg BID treatment group will receive apremilast 30 mg tablets orally twice daily for the first 16 weeks Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to apremilast 30 mg tablets) orally twice daily for the first 16 weeks
Arm Title
Arm B - Apremilast 30 mg
Arm Type
Experimental
Arm Description
All subjects will receive apremilast 30 mg tablets orally twice daily after the Week 16 Visit through the end of the Apremilast Extension Phase of the study
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
CC-10004, Otezla
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Percentage of Participants With a Modified sPGA-G Response at Week 16
Description
The modified sPGA-G is the assessment by the Investigator of the participant's psoriasis lesions' overall disease severity in the genital area at the time of evaluation. The modified sPGA-G is a 5-point scale ranging from clear (0), almost clear (1), mild (2), moderate (3), to severe (4), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, plaque elevation, and scaling.
A modified sPGA-G response is defined as modified sPGA-G score of clear (0) or almost clear (1) and with ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the multiple imputation (MI) method. Two-sided 95% confidence intervals (CIs) for the within-group proportions were based on the Wilson-score method.
Time Frame
Baseline and Week 16 of the Placebo-controlled Phase
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16
Description
The sPGA is the 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), 1 (almost clear), 3 (moderate) to 4 (severe), incorporating an assessment 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 ≥ 2-point reduction from Baseline at Week 16.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Percentage of Participants With a Genital Psoriasis Itch Numeric Rating Scale (GPI-NRS) Response at Week 16
Description
The GPI-NRS is a self-reported measure where participants were asked to assess their psoriasis symptoms in the genital area and select a number on a scale of 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch.
A GPI-NRS response is defined as ≥ 4 point reduction (improvement) from Baseline.
Missing values were imputed using the MI method. Two-sided 95% CIs for the within-group proportions were based on the Wilson-score method.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Change 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 BSA).
A negative change from Baseline indicates a reduction of affected BSA.
Based on mixed-effect model for repeated measures (MMRM) model.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) 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 participant 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 0-30, where 0 represents the best score, and 30 represents the worst health-related quality of life.
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
Change From Baseline in Genital Psoriasis Symptoms Scale (GPSS) Total Score at Week 16
Description
The GPSS is a self-reported measure where participants were asked to assess each of their psoriasis symptoms (itch, pain, discomfort, stinging, burning, redness, scaling, and cracking) in the genital area and select a number on a scale of 0-10, where 0 represents no symptoms, and 10 represents the worst imaginable.
Results from each symptom assessment were summed to generate a total GPSS score ranging from 0 (no genital psoriasis symptoms) to 80 (worst imaginable genital psoriasis symptoms).
A negative change from Baseline indicates an improvement in genital psoriasis symptoms.
Time Frame
Baseline and Week 16 of the placebo-controlled phase
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 is ≥ 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 moderate or severe psoriasis of the genital area at Screening and Baseline.
Subject must have a diagnosis of moderate or severe psoriasis at Screening and Baseline.
Subject must have plaque psoriasis (BSA ≥ 1%) in a non-genital area at both Screening and Baseline.
Subject must have been inadequately controlled with or intolerant of topical therapy, or topical therapy is inappropriate for the treatment of psoriasis affecting the genital area.
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
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subject has any significant medical condition or laboratory abnormality, that would prevent the subject from participating in the study.
Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
Subject has positive Hepatitis B surface antigen or anti-hepatitis C antibody at Screening.
Subject has active tuberculosis (TB) or a history of incompletely treated TB.
Subject has prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
Subject has current or planned therapies that may have a possible effect on psoriasis of the body and/or genital area during the course of the treatment phase of the trial
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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Glick Skin Institute
City
Margate
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Facility Name
International Dermatology Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Skin Care Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Adult and Pediatric Dermatology
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
ActivMed Practices and Research Inc
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
J Woodson Dermatology and Associates
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Las Vegas Dermatology
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
ActivMed
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Stony Brook Dermatology Associates
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Oakview Dermatology
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Ohio State University Medical Center
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Paddington Testing Company Inc
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Clinical Partners LLC
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Virginia Clinical Research Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bellevue Dermatology Clinic
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
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
Centre Hospitalier Universitaire Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Guenther Dermatology Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P1X2
Country
Canada
Facility Name
K Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
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
Skincare Studio
City
St. John's
ZIP/Postal Code
A1E 1V4
Country
Canada
Facility Name
Hopital Claude Huriez CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nice Archet I
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Larrey University Hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Hautklinik Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein, Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Presidio Ospedaliero della Misericordia
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore
City
LAquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Azienda Ospedaliera Di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi Melacrino Morelli
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina
City
Terracina
ZIP/Postal Code
04019
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata di Trieste
City
Trieste
ZIP/Postal Code
34125
Country
Italy
Facility Name
GCM Medical Group, PSC
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
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
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis
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