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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: Apremilast (CC-10004)

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 Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Centre Hospitalier Universitaire Saint Pierre
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St Luc
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2G 1B1
      • Kirk Barber Research
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Children's Hospital
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Enverus Medical Research
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic Dermatology Research
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Karma Clinical Trials
  • Ontario
    • Toronto, Ontario, Canada, M5A 3R6
      • AvantDerm
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Saint-Justine
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Praha, Czechia, 120 00
    • Synexus Czech sro
  • Praha 1, Czechia, 110 00
    • Fakultni nemocnice Kralovske Vinohrady
• France
  • Argenteuil, France, 95107
    • Centre Hospitalier Victor Dupouy Argenteuil
  • Bron cedex, France, 69677
    • Centre Hospitalier Universitaire Lyon
  • Martigues, France, 13500
    • Cabinet du Docteur Ruer-Mulard Mireille
  • Nantes, France, 44093
    • Hotel Dieu CHU Nantes
  • Nice, France, 06202
    • Centre Hospitalier Universitaire de Nice
  • Paris Cedex 15, France, 75015
    • Hôpital Necker
  • Quimper, France, 29018
    • Centre Hospitalier de Cornouaille - Hopital Laennec
  • Saint-Priest En Jarrez, France, 42055
    • CHU Saint Etienne Hopital Nord
  • Toulouse Cedex 9, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
  • Valence, France, 26000
    • Centre Hospitalier de Valence
• Israel
  • Ramat Gan, Israel, 5262000
    • Chaim Sheba Medical Center
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
  • Cagliari, Italy, 09124
    • Azienda Ospedaliera Universitaria di Cagliari
  • Milano, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Universitaria Federico II
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Reggio Emilia, Italy, 42123
    • Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
  • Roma, Italy, 00144
    • Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
• Netherlands
  • NIjmegen, Netherlands
    • Radboud University Medical Center
• Russian Federation
  • Barnaul, Russian Federation, 656038
    • Altai State Medical University
  • Chelyabinsk, Russian Federation, 454092
    • Chelyabinsk Regional Clinical Skin and Venereal Dispensary
  • Ekaterinburg, Russian Federation, 620076
    • Ural Scientific Research Institute of Dermatovenereology and Immunopathology
  • Kazan, Russian Federation, 420004
    • Republican Clinical Dermatology and Venerology Dispensary
  • Krasnodar, Russian Federation, 350020
    • Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
  • Moscow, Russian Federation, 107076
    • State Scientific Center for Dermatovenereology and Cosmetology
  • Moscow, Russian Federation, 117997
    • Russian Children's Clinical Hospital
  • Moscow, Russian Federation, 119071
    • Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
  • Moscow, Russian Federation, 119991
    • National Medical Research Center for Children's Health
  • Novosibirsk, Russian Federation, 630099
    • LLC Medical Center Zdorovaya Semiya
  • Saint Petersburg, Russian Federation, 191123
    • Pierre Wolkenshtein Skin Diseases Clinic LLC
  • Saint Petersburg, Russian Federation, 196158
    • LLC PiterKlinika
  • Saint Petesburg, Russian Federation, 194100
    • Saint Petersburg State Pediatric Medical University
  • Ufa, Russian Federation, 450008
    • Bashkiria State Medical University
  • Yaroslavl, Russian Federation, 150000
    • Yarosavl State Medical Academy
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol Can Ruti
  • Barcelona, Spain, 08950
    • Hospital Sant Joan de Déu
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Cordoba, Spain, 14001
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesús
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Pontevedra, Spain, 36001
    • Complexo Hospitalario de Pontevedra
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio - PPDS
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Marques de Valdecilla
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Hospital General Universitario de Alicante
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Childrens Hospital
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology Clinic
  • California
    • Beverly Hills, California, United States, 90212
      • Zenith Research Inc.
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Laguna Niguel, California, United States, 92677
      • Avance Clinical Trials
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Luis Obispo, California, United States, 93401
      • Coastal Family Dermatology
    • Santa Monica, California, United States, 90404
      • University of California Los Angeles
    • Thousand Oaks, California, United States, 91320
      • California Dermatology Institute
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Solutions Through Advanced Research Inc
    • Margate, Florida, United States, 33063
      • Glick Skin Institute Clinical Research
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Miami, Florida, United States, 33173
      • Ciocca Dermatology
    • Tampa, Florida, United States, 33612-4742
      • University of South Florida Health Morsani Center for Advanced Healthcare
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60602
      • DeNova Research
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Dermatology Group Inc
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Epiphany Dermatology of Kansas, LLC
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ActivMed Practices and Research Inc
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Henderson, Nevada, United States, 89052
      • J Woodson Dermatology and Associates Ltd
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Forest Hills, New York, United States, 11375
      • Forest Hills Dermatology Group
    • Manhasset, New York, United States, 11030
      • SUNY downstate Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center
    • Fairborn, Ohio, United States, 45324
      • Wright State Physicians
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Essential Medical Research, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Childrens Hospital
    • Dallas, Texas, United States, 75231
      • Modern Research Associates PLLC
    • Houston, Texas, United States, 77065
      • Mosaic Dermatology
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
  • Utah
    • West Jordan, Utah, United States, 84088
      • Jordan Valley Dermatology Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin Hospital and Clinics
    • Milwaukee, Wisconsin, United States, 53226
      • Childrens Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Baseline to Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved At Least 75% Reduction in Psoriasis Area Severity Index (PASI-75) From Baseline at 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.	Baseline and Week 16
Percentage of Participants Who Achieved At Least 50% Reduction in Psoriasis Area Severity Index (PASI-50) From Baseline 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. 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.	Baseline and Week 16
Percentage Change From Baseline in Total 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. 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.	Baseline and Week 16
Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at 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.	Baseline and Week 16
Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of 0 or 1 at 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.	Week 16
Change From Baseline in CDLQI Score at 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.	Baseline and Week 16
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase	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.	16 weeks
Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period	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.	52 weeks
Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase	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.	16 weeks
Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period	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.	52 weeks
Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase	A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.	16 weeks
Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period	A TREAE is any AE that is determined by the Investigator to have a possibly causal relationship to the investigational product.	52 weeks
Number of Participants With Diarrhea During the Placebo-controlled Phase	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.	Up to approximately 113 days
Number of Participants With Diarrhea During the Apremilast Exposure Period	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.	Day 1 up to approximately 365 days
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase	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.	Up to approximately 113 days
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period	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.	Day 1 up to approximately 365 days
Number of Participants With Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Placebo-controlled Phase	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.	16 weeks
Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase	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.	Week 16 to Week 52
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development	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.	Week 52
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development	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.	Week 52
Mean Body Weight of Participants During the Placebo-controlled Phase	The participants' body weight in kilograms (kg) was recorded.	Baseline and Week 16
Mean Body Weight of Participants During the Apremilast Exposure Period	The participants' body weight in kilograms (kg) was recorded.	Baseline and Week 52
Mean Height of Participants During the Placebo-controlled Phase	The participants' height in centimeters (cm) was recorded.	Baseline and Week 16
Mean Height of Participants During the Apremilast Exposure Period	The participants' height in centimeters (cm) was recorded.	Baseline and Week 52
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase	The participants' BMI was calculated as body weight (kg)/height (m^2).	Baseline and Week 16
Mean BMI of Participants During the Apremilast Exposure Period	The participants' BMI was calculated as body weight (kg)/height (m^2).	Baseline and Week 52
Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase	A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.	16 weeks
Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period	A psoriasis flare was defined as a sudden intensification of psoriasis (new generalized erythrodermic, inflammatory or pustular psoriasis) requiring medical intervention beyond allowable medications.	52 weeks
Number of Participants Who Experienced a Psoriasis Rebound	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.	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)

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Fiorillo L, Becker E, de Lucas R, Belloni-Fortina A, Armesto S, Elewski B, Maes P, Oberoi RK, Paris M, Zhang W, Zhang Z, Arkin L. Efficacy and safety of apremilast in pediatric patients with moderate-to-severe plaque psoriasis: 16-week results from SPROUT, a randomized controlled trial. J Am Acad Dermatol. 2024 Jun;90(6):1232-1239. doi: 10.1016/j.jaad.2023.11.068. Epub 2024 Jan 23.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Adolescents; Psoriasis; Children; Pediatric; Plaque Psoriasis; CC-10004; Apremilast; Otezla; 6 through 17 years; SPROUT
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: CC-10004-PPSO-003; U1111-1219-3112 (Registry Identifier: WHO); 2018-002918-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No