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Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast (CC-10004)
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Pediatric, 6 through 17 years, Plaque Psoriasis, Psoriasis, CC-10004, Apremilast, Otezla, Children, Adolescents, SPROUT

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
  2. Subjects must have a weight of ≥ 20 kg
  3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.

  4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:

    • PASI score ≥ 12; and
    • Body surface area (BSA) ≥ 10%; and
    • sPGA ≥ 3 (moderate to severe)
  5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
  6. Candidate for systemic therapy or phototherapy

Exclusion Criteria:

  1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
  2. Psoriasis flare or rebound within 4 weeks prior to Screening
  3. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
  4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline

  5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis

    a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)

    Exceptions*:

    i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions

    *Subjects should not use these topical treatments within 24 hours prior to the clinic visit.

    b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).

Sites / Locations

  • University of Alabama Birmingham
  • Phoenix Childrens Hospital
  • Johnson Dermatology Clinic
  • Zenith Research Inc.
  • First OC Dermatology
  • Avance Clinical Trials
  • Stanford University
  • Coastal Family Dermatology
  • University of California Los Angeles
  • California Dermatology Institute
  • Solutions Through Advanced Research Inc
  • Glick Skin Institute Clinical Research
  • University of Miami Hospital
  • Ciocca Dermatology
  • University of South Florida Health Morsani Center for Advanced Healthcare
  • Skin Care Physicians of Georgia
  • Treasure Valley Medical Research
  • DeNova Research
  • Dawes Fretzin Dermatology Group Inc
  • Epiphany Dermatology of Kansas, LLC
  • ActivMed Practices and Research Inc
  • Mayo Clinic
  • J Woodson Dermatology and Associates Ltd
  • Dartmouth Hitchcock Medical Center
  • Montefiore Medical Center
  • Forest Hills Dermatology Group
  • SUNY Downstate Medical Center
  • Cincinnati Childrens Hospital Medical Center
  • Wright State Physicians
  • Essential Medical Research, LLC
  • Medical University of South Carolina
  • Arlington Research Center
  • Driscoll Childrens Hospital
  • Modern Research Associates PLLC
  • Mosaic Dermatology
  • Texas Dermatology and Laser Specialists
  • Jordan Valley Dermatology Center
  • University of Wisconsin Hospital and Clinics
  • Childrens Hospital of Wisconsin
  • Centre Hospitalier Universitaire Saint Pierre
  • Cliniques Universitaires St Luc
  • Universitair Ziekenhuis Gent
  • Kirk Barber Research
  • Stollery Children's Hospital
  • Enverus Medical Research
  • Winnipeg Clinic Dermatology Research
  • Karma Clinical Trials
  • AvantDerm
  • CHU Saint-Justine
  • Fakultni nemocnice Hradec Kralove
  • Fakultni nemocnice Kralovske Vinohrady
  • Synexus Czech sro
  • Centre Hospitalier Victor Dupouy Argenteuil
  • Centre Hospitalier Universitaire Lyon
  • Cabinet du Docteur Ruer-Mulard Mireille
  • Hotel Dieu CHU Nantes
  • Centre Hospitalier Universitaire de Nice
  • Hopital Necker
  • Centre Hospitalier de Cornouaille - Hopital Laennec
  • CHU Saint Etienne Hopital Nord
  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Centre Hospitalier de Valence
  • Chaim Sheba Medical Center
  • Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
  • Azienda Ospedaliera Universitaria di Cagliari
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
  • Policlinico Tor Vergata
  • Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
  • Radboud university medical center
  • Altai State Medical University
  • Chelyabinsk Regional Clinical Skin and Venereal Dispensary
  • Ural Scientific Research Institute of Dermatovenereology and Immunopathology
  • Republican Clinical Dermatology and Venerology Dispensary
  • Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
  • State Scientific Center for Dermatovenereology and Cosmetology
  • Russian Children's Clinical Hospital
  • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
  • National Medical Research Center for Children's Health
  • LLC Medical Center Zdorovaya Semiya
  • Pierre Wolkenshtein Skin Diseases Clinic LLC
  • LLC PiterKlinika
  • Saint Petersburg State Pediatric Medical University
  • Bashkiria State Medical University
  • Yarosavl State Medical Academy
  • Hospital Marques de Valdecilla
  • Hospital General Universitario de Alicante
  • Hospital Universitari Germans Trias i Pujol Can Ruti
  • Hospital Sant Joan de Deu
  • Hospital Puerta del Mar
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario Gregorio Maranon
  • Hospital Infantil Universitario Nino Jesus
  • Hospital 12 de Octubre
  • Hospital La Paz
  • Complexo Hospitalario De Pontevedra
  • Hospital Universitario Virgen del Rocio - PPDS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Administration of Apremilast (CC-10004) - 20mg

Administration of Apremilast (CC-10004) - 30mg

Administration of Placebo

Arm Description

Apremilast 20mg Twice Daily (BID)

Apremilast 30mg Twice Daily (BID)

Placebo tablet Twice Daily (BID)

Outcomes

Primary Outcome Measures

Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
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) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.

Secondary Outcome Measures

Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Proportion of subjects who achieve at least a 50% reduction in PASI (PASI-50) from baseline
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Percent change from baseline in total PASI score
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Percent change from baseline in affected Body Surface Area (BSA)
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand, which equates to approximately 1% of total body surface area.
Proportion of subjects who achieve CDLQI (0/1)
The CDLQI is designed to measure the impact of skin disease on children's quality of life.
Change from baseline in CDLQI score
The CDLQI is designed to measure the impact of skin disease on children's quality of life.
Adverse Events (AEs)
Number of subjects with adverse event
Stool Diary
Symptoms of bowel movement will be collected using a daily stool diary
Columbia-Suicide Severity Rating Scale (C-SSRS)
Questionnaire designed to determine any risk of self-harm by the study subject
Tanner Stages
Tanner Stages is a scale defining physical measurements of sexual development based on external primary and secondary sex characteristics
Psoriasis disease flare
Proportion of subjects with sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications
Psoriasis Rebound
Severe and sudden worsening of disease (PASI ≥ 125% of baseline or new generalized, pustular, erythrodermic psoriasis) after treatment has been discontinued
Height Measurement
Height is measured and recorded at each visit
Weight Measurement
Weight is measured and recorded at each visit

Full Information

First Posted
August 30, 2018
Last Updated
March 28, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT03701763
Brief Title
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Official Title
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
March 27, 2023 (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
Yes

5. Study Description

Brief Summary
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Detailed Description
Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20 mg BID or placebo BID and subjects ≥ 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Pediatric, 6 through 17 years, Plaque Psoriasis, Psoriasis, CC-10004, Apremilast, Otezla, Children, Adolescents, SPROUT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Administration of Apremilast (CC-10004) - 20mg
Arm Type
Experimental
Arm Description
Apremilast 20mg Twice Daily (BID)
Arm Title
Administration of Apremilast (CC-10004) - 30mg
Arm Type
Experimental
Arm Description
Apremilast 30mg Twice Daily (BID)
Arm Title
Administration of Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet Twice Daily (BID)
Intervention Type
Drug
Intervention Name(s)
Apremilast (CC-10004)
Intervention Description
Apremilast (CC-10004)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
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) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
Time Frame
Up to week 16
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Time Frame
Up to week 16
Title
Proportion of subjects who achieve at least a 50% reduction in PASI (PASI-50) from baseline
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Time Frame
Up to week 16
Title
Percent change from baseline in total PASI score
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. The PASI is a validated instrument that has become standard in clinical trials for psoriasis.
Time Frame
Up to week 16
Title
Percent change from baseline in affected Body Surface Area (BSA)
Description
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand, which equates to approximately 1% of total body surface area.
Time Frame
Up to week 16
Title
Proportion of subjects who achieve CDLQI (0/1)
Description
The CDLQI is designed to measure the impact of skin disease on children's quality of life.
Time Frame
Up to week 16
Title
Change from baseline in CDLQI score
Description
The CDLQI is designed to measure the impact of skin disease on children's quality of life.
Time Frame
Up to week 16
Title
Adverse Events (AEs)
Description
Number of subjects with adverse event
Time Frame
From enrollment until at least 28 days after completion of study treatment
Title
Stool Diary
Description
Symptoms of bowel movement will be collected using a daily stool diary
Time Frame
From Baseline up to week 56
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Questionnaire designed to determine any risk of self-harm by the study subject
Time Frame
From Baseline up to Week 52
Title
Tanner Stages
Description
Tanner Stages is a scale defining physical measurements of sexual development based on external primary and secondary sex characteristics
Time Frame
At Baseline and week 52
Title
Psoriasis disease flare
Description
Proportion of subjects with sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications
Time Frame
From Baseline up to week 52
Title
Psoriasis Rebound
Description
Severe and sudden worsening of disease (PASI ≥ 125% of baseline or new generalized, pustular, erythrodermic psoriasis) after treatment has been discontinued
Time Frame
4 week follow-up, 8 week follow-up, and 14 week follow-up visits
Title
Height Measurement
Description
Height is measured and recorded at each visit
Time Frame
Up to week 66
Title
Weight Measurement
Description
Weight is measured and recorded at each visit
Time Frame
Up to week 66

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian Subjects must have a weight of ≥ 20 kg Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by: PASI score ≥ 12; and Body surface area (BSA) ≥ 10%; and sPGA ≥ 3 (moderate to severe) Disease inadequately controlled by or inappropriate for topical therapy for psoriasis Candidate for systemic therapy or phototherapy Exclusion Criteria: Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline Psoriasis flare or rebound within 4 weeks prior to Screening Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol) Exceptions*: i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions *Subjects should not use these topical treatments within 24 hours prior to the clinic visit. b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).
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 Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Johnson Dermatology Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Zenith Research Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Avance Clinical Trials
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Coastal Family Dermatology
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
California Dermatology Institute
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Facility Name
Solutions Through Advanced Research Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Glick Skin Institute Clinical Research
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ciocca Dermatology
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
University of South Florida Health Morsani Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-4742
Country
United States
Facility Name
Skin Care Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Treasure Valley Medical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
DeNova Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Dawes Fretzin Dermatology Group Inc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Epiphany Dermatology of Kansas, LLC
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
ActivMed Practices and Research Inc
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
J Woodson Dermatology and Associates Ltd
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Forest Hills Dermatology Group
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
Essential Medical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Arlington Research Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Driscoll Childrens Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Modern Research Associates PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mosaic Dermatology
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Jordan Valley Dermatology Center
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Childrens Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
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
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2G 1B1
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Enverus Medical Research
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Winnipeg Clinic Dermatology Research
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
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
AvantDerm
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5A 3R6
Country
Canada
Facility Name
CHU Saint-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Synexus Czech sro
City
Praha
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Centre Hospitalier Victor Dupouy Argenteuil
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Centre Hospitalier Universitaire Lyon
City
Bron cedex
ZIP/Postal Code
69677
Country
France
Facility Name
Cabinet du Docteur Ruer-Mulard Mireille
City
Martigues
ZIP/Postal Code
13500
Country
France
Facility Name
Hotel Dieu CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Necker
City
Paris Cedex 15
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier de Cornouaille - Hopital Laennec
City
Quimper
ZIP/Postal Code
29018
Country
France
Facility Name
CHU Saint Etienne Hopital Nord
City
Saint-Priest En Jarrez
ZIP/Postal Code
42055
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Centre Hospitalier de Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Cagliari
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Radboud university medical center
City
NIjmegen
Country
Netherlands
Facility Name
Altai State Medical University
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
City
Ekaterinburg
ZIP/Postal Code
620076
Country
Russian Federation
Facility Name
Republican Clinical Dermatology and Venerology Dispensary
City
Kazan
ZIP/Postal Code
420004
Country
Russian Federation
Facility Name
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
State Scientific Center for Dermatovenereology and Cosmetology
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Russian Children's Clinical Hospital
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
City
Moscow
ZIP/Postal Code
119071
Country
Russian Federation
Facility Name
National Medical Research Center for Children's Health
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
LLC Medical Center Zdorovaya Semiya
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Pierre Wolkenshtein Skin Diseases Clinic LLC
City
Saint Petersburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
LLC PiterKlinika
City
Saint Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
Saint Petersburg State Pediatric Medical University
City
Saint Petesburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Bashkiria State Medical University
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
Yarosavl State Medical Academy
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Hospital Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
State/Province
Comunidad Valenciana
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol Can Ruti
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan de Deu
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Complexo Hospitalario De Pontevedra
City
Pontevedra
ZIP/Postal Code
36001
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - PPDS
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

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

Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

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