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

• ClinicalTrials.gov Identifier: NCT03701763
• Recruitment Status: Terminated
• First Posted: October 10, 2018
• Results First Posted: December 7, 2023
• Last Update Posted: December 7, 2023
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Apremilast (CC-10004); Other: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 245 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 19, 2018
• Actual Primary Completion Date: April 25, 2022
• Actual Study Completion Date: March 27, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Administration of Apremilast (CC-10004) - 20mg; Apremilast 20mg Twice Daily (BID)	Drug: Apremilast (CC-10004); Apremilast (CC-10004)
Experimental: Administration of Apremilast (CC-10004) - 30mg; Apremilast 30mg Twice Daily (BID)	Drug: Apremilast (CC-10004); Apremilast (CC-10004)
Placebo Comparator: Administration of Placebo; Placebo tablet Twice Daily (BID)	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 [ Time Frame: Baseline to Week 16 ]
   The sPGA is the assessment by the Investigator of the overall disease severity of plaque psoriasis 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. The results presented are for the percentage of participants with a sPGA response. An sPGA response was defined as a score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at Week 16 [ Time Frame: Baseline and Week 16 ]
   The Psoriasis Area Severity Index (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 scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-75. PASI-75 was defined as at least a 75% reduction in PASI score from baseline.
2. Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline at Week 16 [ Time Frame: Baseline and 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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The results presented are for the percentage of participants with PASI-50. PASI-50 was defined as at least a 50% reduction in PASI score from baseline.
3. Percentage Change From Baseline in Total PASI Score at Week 16 [ Time Frame: Baseline and 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. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Positive percentage change from baseline scores indicate a worsening of disease severity, and negative percentage change from baseline scores indicate an improvement in disease severity.
4. Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 [ Time Frame: Baseline and Week 16 ]
   BSA is a measurement of involved skin of the whole body affected by psoriasis, which ranges from 0% to 100%. Positive percentage change from baseline indicates that a greater BSA was affected by psoriasis. A negative percentage change from baseline indicates that a lesser BSA was affected by psoriasis.
5. Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at Week 16 [ Time Frame: Week 16 ]
   The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). The results presented are for the percentage of participants who achieved a total CDLQI score of 0 or 1 at Week 16.
6. Change From Baseline in CDLQI Score at Week 16 [ Time Frame: Baseline and Week 16 ]
   The CDLQI is designed to measure the impact of skin disease on children's quality of life. The CDLQI measures how much the participant's psoriasis has affected them over the last week, and includes 10 questions with possible answers ranging from not at all (score of 0) to very much (score of 3). The CDLQI total score ranged from 0 (no effect on the participant's life) to 30 (extremely large effect on the participant's life). A positive change from baseline score indicates that a participant's quality of life has worsened. A negative change from baseline score indicates that a participant's quality of life has improved.
7. Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase [ Time Frame: 16 weeks ]
   An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
8. Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period [ Time Frame: 52 weeks ]
   An AE was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of the study. A TEAE is any AE that occurred after first dose of the investigational product.
9. Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase [ Time Frame: 16 weeks ]
   A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
10. Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period [ Time Frame: 52 weeks ]
    A TESAE is any AE occurring at any dose after first dose that results in death, is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE), requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay), results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions), is a congenital anomaly/birth defect, or constitutes an important medical event.
11. Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase [ Time Frame: 16 weeks ]
    A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
12. Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period [ Time Frame: 52 weeks ]
    A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.
13. Number of Participants With Diarrhea During the Placebo-controlled Phase [ Time Frame: Up to approximately 113 days ]
    Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
14. Number of Participants With Diarrhea During the Apremilast Exposure Period [ Time Frame: Day 1 up to approximately 365 days ]
    Diarrhea was defined as having 3 or more liquid or watery stools in a day. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
15. Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase [ Time Frame: Up to approximately 113 days ]
    Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
16. Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period [ Time Frame: Day 1 up to approximately 365 days ]
    Diarrhea symptoms were nausea, vomiting, abdominal cramps, abdominal pain, fever, bloating, and other symptoms. Participants and their parent/guardian were supplied with diaries (either paper or electronic) that were filled out daily to record and describe any diarrhea and associated symptoms.
17. Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase [ Time Frame: 16 weeks ]
    The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
18. Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase [ Time Frame: Week 16 to Week 52 ]
    The C-SSRS is a questionnaire that is used to assess suicidal ideation and behavior. The C-SSRS questionnaire measures suicidal ideation, intensity of ideation, and suicidal behaviors. Results presented are for the number of participants who recorded suicidal ideation or behavior on the C-SSRS.
19. Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development [ Time Frame: Week 52 ]
    The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
20. Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development [ Time Frame: Week 52 ]
    The Tanner Staging of sexual development is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on characteristics, such as the size of the breasts, genitals, testicular volume, and growth of pubic hair. The scale ranges from stage I (pre-adolescent) to stage V (adult development). The results presented are for the number of participants at stage I-V of development.
21. Mean Body Weight of Participants During the Placebo-controlled Phase [ Time Frame: Baseline and Week 16 ]
    The participants' body weight in kilograms (kg) was recorded.
22. Mean Body Weight of Participants During the Apremilast Exposure Period [ Time Frame: Baseline and Week 52 ]
    The participants' body weight in kilograms (kg) was recorded.
23. Mean Height of Participants During the Placebo-controlled Phase [ Time Frame: Baseline and Week 16 ]
    The participants' height in centimeters (cm) was recorded.
24. Mean Height of Participants During the Apremilast Exposure Period [ Time Frame: Baseline and Week 52 ]
    The participants' height in centimeters (cm) was recorded.
25. Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase [ Time Frame: Baseline and Week 16 ]
    The participants' BMI was calculated as body weight (kg)/height (m^2).
26. Mean BMI of Participants During the Apremilast Exposure Period [ Time Frame: Baseline and Week 52 ]
    The participants' BMI was calculated as body weight (kg)/height (m^2).
27. Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase [ Time Frame: 16 weeks ]
    A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
28. Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period [ Time Frame: 52 weeks ]
    A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.
29. Number of Participants Who Experienced a Psoriasis Rebound [ Time Frame: 14 weeks post last dose (max mean treatment duration in placebo-controlled phase was 15.3 weeks, and 41.9 weeks in the apremilast-exposure period) ]
    A psoriasis rebound was defined as an adverse event of psoriasis that started after the last dose date for participants who received treatment in the study.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

United States, Alabama

University of Alabama Birmingham

Birmingham, Alabama, United States, 35233

United States, Arizona

Phoenix Childrens Hospital

Phoenix, Arizona, United States, 85016

United States, Arkansas

Johnson Dermatology Clinic

Fort Smith, Arkansas, United States, 72916

United States, California

Zenith Research Inc.

Beverly Hills, California, United States, 90212

First OC Dermatology

Fountain Valley, California, United States, 92708

Avance Clinical Trials

Laguna Niguel, California, United States, 92677

Stanford University

Palo Alto, California, United States, 94304

Coastal Family Dermatology

San Luis Obispo, California, United States, 93401

University of California Los Angeles

Santa Monica, California, United States, 90404

California Dermatology Institute

Thousand Oaks, California, United States, 91320

United States, Florida

Solutions Through Advanced Research Inc

Jacksonville, Florida, United States, 32256

Glick Skin Institute Clinical Research

Margate, Florida, United States, 33063

University of Miami Hospital

Miami, Florida, United States, 33136

Ciocca Dermatology

Miami, Florida, United States, 33173

University of South Florida Health Morsani Center for Advanced Healthcare

Tampa, Florida, United States, 33612-4742

United States, Georgia

Skin Care Physicians of Georgia

Macon, Georgia, United States, 31217

United States, Idaho

Treasure Valley Medical Research

Meridian, Idaho, United States, 83646

United States, Illinois

DeNova Research

Chicago, Illinois, United States, 60602

United States, Indiana

Dawes Fretzin Dermatology Group Inc

Indianapolis, Indiana, United States, 46256

United States, Kansas

Epiphany Dermatology of Kansas, LLC

Overland Park, Kansas, United States, 66210

United States, Massachusetts

ActivMed Practices and Research Inc

Beverly, Massachusetts, United States, 01915

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Nevada

J Woodson Dermatology and Associates Ltd

Henderson, Nevada, United States, 89052

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

Forest Hills Dermatology Group

Forest Hills, New York, United States, 11375

SUNY Downstate Medical Center

Manhasset, New York, United States, 11030

United States, Ohio

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Wright State Physicians

Fairborn, Ohio, United States, 45324

United States, Oklahoma

Essential Medical Research, LLC

Tulsa, Oklahoma, United States, 74137

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Texas

Arlington Research Center

Arlington, Texas, United States, 76011

Driscoll Childrens Hospital

Corpus Christi, Texas, United States, 78411

Modern Research Associates PLLC

Dallas, Texas, United States, 75231

Mosaic Dermatology

Houston, Texas, United States, 77065

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

United States, Utah

Jordan Valley Dermatology Center

West Jordan, Utah, United States, 84088

United States, Wisconsin

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States, 53715

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Belgium

Centre Hospitalier Universitaire Saint Pierre

Brussels, Belgium, 1000

Cliniques Universitaires St Luc

Bruxelles, Belgium, 1200

Universitair Ziekenhuis Gent

Gent, Belgium, 9000

Canada, Alberta

Kirk Barber Research

Calgary, Alberta, Canada, T2G 1B1

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Canada, British Columbia

Enverus Medical Research

Surrey, British Columbia, Canada, V3R 6A7

Canada, Manitoba

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, Canada, R3C 0N2

Canada, Newfoundland and Labrador

Karma Clinical Trials

Saint John's, Newfoundland and Labrador, Canada, A1A 4Y3

Canada, Ontario

AvantDerm

Toronto, Ontario, Canada, M5A 3R6

Canada, Quebec

CHU Saint-Justine

Montreal, Quebec, Canada, H3T 1C5

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

Fakultni nemocnice Kralovske Vinohrady

Praha 1, Czechia, 110 00

Synexus Czech sro

Praha, Czechia, 120 00

France

Centre Hospitalier Victor Dupouy Argenteuil

Argenteuil, France, 95107

Centre Hospitalier Universitaire Lyon

Bron cedex, France, 69677

Cabinet du Docteur Ruer-Mulard Mireille

Martigues, France, 13500

Hotel Dieu CHU Nantes

Nantes, France, 44093

Centre Hospitalier Universitaire de Nice

Nice, France, 06202

Hopital Necker

Paris Cedex 15, France, 75015

Centre Hospitalier de Cornouaille - Hopital Laennec

Quimper, France, 29018

CHU Saint Etienne Hopital Nord

Saint-Priest En Jarrez, France, 42055

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse Cedex 9, France, 31059

Centre Hospitalier de Valence

Valence, France, 26000

Israel

Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

Italy

Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

Bologna, Italy, 40138

Azienda Ospedaliera Universitaria di Cagliari

Cagliari, Italy, 09124

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy, 80131

Azienda Ospedaliera di Padova

Padova, Italy, 35128

Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123

Policlinico Tor Vergata

Roma, Italy, 00133

Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

Roma, Italy, 00144

Netherlands

Radboud university medical center

NIjmegen, Netherlands

Russian Federation

Altai State Medical University

Barnaul, Russian Federation, 656038

Chelyabinsk Regional Clinical Skin and Venereal Dispensary

Chelyabinsk, Russian Federation, 454092

Ural Scientific Research Institute of Dermatovenereology and Immunopathology

Ekaterinburg, Russian Federation, 620076

Republican Clinical Dermatology and Venerology Dispensary

Kazan, Russian Federation, 420004

Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

Krasnodar, Russian Federation, 350020

State Scientific Center for Dermatovenereology and Cosmetology

Moscow, Russian Federation, 107076

Russian Children's Clinical Hospital

Moscow, Russian Federation, 117997

Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

Moscow, Russian Federation, 119071

National Medical Research Center for Children's Health

Moscow, Russian Federation, 119991

LLC Medical Center Zdorovaya Semiya

Novosibirsk, Russian Federation, 630099

Pierre Wolkenshtein Skin Diseases Clinic LLC

Saint Petersburg, Russian Federation, 191123

LLC PiterKlinika

Saint Petersburg, Russian Federation, 196158

Saint Petersburg State Pediatric Medical University

Saint Petesburg, Russian Federation, 194100

Bashkiria State Medical University

Ufa, Russian Federation, 450008

Yarosavl State Medical Academy

Yaroslavl, Russian Federation, 150000

Spain

Hospital Marques de Valdecilla

Santander, Cantabria, Spain, 39008

Hospital General Universitario de Alicante

Alicante, Comunidad Valenciana, Spain, 03010

Hospital Universitari Germans Trias i Pujol Can Ruti

Badalona, Spain, 08916

Hospital Sant Joan de Deu

Barcelona, Spain, 08950

Hospital Puerta del Mar

Cadiz, Spain, 11009

Hospital Universitario Reina Sofia

Cordoba, Spain, 14001

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Hospital Infantil Universitario Nino Jesus

Madrid, Spain, 28009

Hospital 12 de Octubre

Madrid, Spain, 28041

Hospital La Paz

Madrid, Spain, 28046

Complexo Hospitalario De Pontevedra

Pontevedra, Spain, 36001

Hospital Universitario Virgen del Rocio - PPDS

Sevilla, Spain, 41013

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

  Study Documents (Full-Text)

Documents provided by Amgen:

Study Protocol  [PDF] December 17, 2021

Statistical Analysis Plan  [PDF] December 20, 2021

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT03701763
• Other Study ID Numbers: CC-10004-PPSO-003; U1111-1219-3112 ( Registry Identifier: WHO ); 2018-002918-12 ( EudraCT Number )
• First Posted: October 10, 2018
• Results First Posted: December 7, 2023
• Last Update Posted: December 7, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• 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.
• URL: http://www.amgen.com/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:

Pediatric; 6 through 17 years; Plaque Psoriasis; Psoriasis; CC-10004; Apremilast; Otezla; Children; Adolescents; SPROUT

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Apremilast; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Phosphodiesterase 4 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action