PsoriasisPhase 3NCT03701763
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 study testing Apremilast (CC-10004) in people with Psoriasis, run by Amgen at 99 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Apremilast (CC-10004)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 99 sitesin 10 countries
- Study dates
- 19 Dec 2018to 27 Mar 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- sPGA ≥ 3 (moderate to severe)
- Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
- Candidate for systemic therapy or phototherapy
Who cannot join
- 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
- 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)
Show all 10Show fewer
- Exceptions:
- 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.
- 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).
Trial locations and contacts
99 sites in 10 countries.
99 sites in 10 countries
United States39 sites
Arlington Research Center
Arlington, Texas, 76011
ActivMed Practices and Research Inc
Beverly, Massachusetts, 01915
Zenith Research Inc.
Beverly Hills, California, 90212
University of Alabama Birmingham
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
DeNova Research
Chicago, Illinois, 60602
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Driscoll Childrens Hospital
Corpus Christi, Texas, 78411
Modern Research Associates PLLC
Dallas, Texas, 75231
Wright State Physicians
Fairborn, Ohio, 45324
Forest Hills Dermatology Group
Forest Hills, New York, 11375
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
First OC Dermatology
Fountain Valley, California, 92708
J Woodson Dermatology and Associates Ltd
Henderson, Nevada, 89052
Mosaic Dermatology
Houston, Texas, 77065
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana, 46256
Solutions Through Advanced Research Inc
Jacksonville, Florida, 32256
Avance Clinical Trials
Laguna Niguel, California, 92677
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Skin Care Physicians of Georgia
Macon, Georgia, 31217
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53715
SUNY Downstate Medical Center
Manhasset, New York, 11030
Glick Skin Institute Clinical Research
Margate, Florida, 33063
Treasure Valley Medical Research
Meridian, Idaho, 83646
University of Miami Hospital
Miami, Florida, 33136
Ciocca Dermatology
Miami, Florida, 33173
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Epiphany Dermatology of Kansas, LLC
Overland Park, Kansas, 66210
Stanford University
Palo Alto, California, 94304
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Mayo Clinic
Rochester, Minnesota, 55905
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Coastal Family Dermatology
San Luis Obispo, California, 93401
University of California Los Angeles
Santa Monica, California, 90404
University of South Florida Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612-4742
Montefiore Medical Center
The Bronx, New York, 10467
California Dermatology Institute
Thousand Oaks, California, 91320
Essential Medical Research, LLC
Tulsa, Oklahoma, 74137
Jordan Valley Dermatology Center
West Jordan, Utah, 84088
Russia15 sites
Altai State Medical University
Barnaul, 656038
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk, 454092
Republican Clinical Dermatology and Venerology Dispensary
Kazan', 420004
Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health
Krasnodar, 350020
State Scientific Center for Dermatovenereology and Cosmetology
Moscow, 107076
Russian Children's Clinical Hospital
Moscow, 117997
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
Moscow, 119071
National Medical Research Center for Children's Health
Moscow, 119991
LLC Medical Center Zdorovaya Semiya
Novosibirsk, 630099
Pierre Wolkenshtein Skin Diseases Clinic LLC
Saint Petersburg, 191123
LLC PiterKlinika
Saint Petersburg, 196158
Saint Petersburg State Pediatric Medical University
Saint Petesburg, 194100
Bashkiria State Medical University
Ufa, 450008
Yarosavl State Medical Academy
Yaroslavl, 150000
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Yekaterinburg, 620076
Spain12 sites
Hospital General Universitario de Alicante
Alicante, Valencia, 03010
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona, 08916
Hospital Sant Joan de Deu
Barcelona, 08950
Hospital Puerta del Mar
Cadiz, 11009
Hospital Universitario Reina Sofia
Córdoba, 14001
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Infantil Universitario Nino Jesus
Madrid, 28009
Hospital 12 de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Complexo Hospitalario De Pontevedra
Pontevedra, 36001
Hospital Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
France10 sites
Centre Hospitalier Victor Dupouy Argenteuil
Argenteuil, 95107
Centre Hospitalier Universitaire Lyon
Bron, 69677
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500
Hotel Dieu CHU Nantes
Nantes, 44093
Centre Hospitalier Universitaire de Nice
Nice, 06202
Hopital Necker
Paris, 75015
Centre Hospitalier de Cornouaille - Hopital Laennec
Quimper, 29018
CHU Saint Etienne Hopital Nord
Saint-Priest En Jarrez, 42055
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31059
Centre Hospitalier de Valence
Valence, 26000
Italy8 sites
Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
Azienda Ospedaliera Universitaria di Cagliari
Cagliari, 09124
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Policlinico Tor Vergata
Roma, 00133
Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica
Roma, 00144
Canada7 sites
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
CHU Saint-Justine
Montreal, Quebec, H3T 1C5
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3
Enverus Medical Research
Surrey, British Columbia, V3R 6A7
AvantDerm
Toronto, Ontario, M5A 3R6
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
Belgium3 sites
Centre Hospitalier Universitaire Saint Pierre
Brussels, 1000
Cliniques Universitaires St Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
Czechia3 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Kralovske Vinohrady
Prague, 110 00
Synexus Czech sro
Prague, 120 00
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Apremilast (CC-10004), Placebo
- Keywords
- Pediatric, 6 through 17 years, Plaque Psoriasis, Psoriasis, CC-10004, Apremilast, Otezla, Children, Adolescents, SPROUT
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast (CC-10004)Drug
Apremilast (CC-10004)
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Administration of Apremilast (CC-10004) - 20mg | Experimental | Apremilast 20mg Twice Daily (BID) Receives: Drug: Apremilast (CC-10004) |
| Administration of Apremilast (CC-10004) - 30mg | Experimental | Apremilast 30mg Twice Daily (BID) Receives: Drug: Apremilast (CC-10004) |
| Administration of Placebo | Placebo comparator | Placebo tablet Twice Daily (BID) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 52
Mean Body Weight of Participants During the Placebo-controlled Phase
The participants' body weight in kilograms (kg) was recorded.
Measured: Baseline and Week 16
Mean Body Weight of Participants During the Apremilast Exposure Period
The participants' body weight in kilograms (kg) was recorded.
Measured: Baseline and Week 52
Mean Height of Participants During the Placebo-controlled Phase
The participants' height in centimeters (cm) was recorded.
Measured: Baseline and Week 16
Mean Height of Participants During the Apremilast Exposure Period
The participants' height in centimeters (cm) was recorded.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start19 Dec 2018
- Primary completion25 Apr 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701763
- Sponsor's protocol ID
- CC-10004-PPSO-003
- Other IDs
- U1111-1219-3112, 2018-002918-12, 2018
- Status last verified
- Dec 2024
- First submitted
- 30 Aug 2018
- Last updated
- 16 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
- Expanded access
- Available
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.
PubMed 38266683
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03701763
- Acronym / sponsor ID
- CC-10004-PPSO-003
- Conditions
- Psoriasis
- Keywords
- Pediatric, 6 through 17 years, Plaque Psoriasis, Psoriasis, CC-10004, Apremilast, Otezla, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 10 Oct 2018 (actual)
- Results
- Posted 7 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of Apremilast (CC-10004) - 20mg | Experimental | Drug: Apremilast (CC-10004)Apremilast 20mg Twice Daily (BID) |
| Administration of Apremilast (CC-10004) - 30mg | Experimental | Drug: Apremilast (CC-10004)Apremilast 30mg Twice Daily (BID) |
| Administration of Placebo | Placebo comparator | Other: PlaceboPlacebo tablet Twice Daily (BID) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apremilast (CC-10004)Apremilast (CC-10004) | Drug | Administration of Apremilast (CC-10004) - 20mg, Administration of Apremilast (CC-10004) - 30mg |
| PlaceboPlacebo | Other | Administration of Placebo |
Primary outcome
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.
29 secondary outcomes
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
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
Percentage Change From Baseline in Total PASI Score at Week 16
Time frame: Baseline and Week 16
Percentage Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16
Time frame: 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
Time frame: Week 16
Change From Baseline in CDLQI Score at Week 16
Time frame: Baseline and Week 16
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) During the Placebo-controlled Phase
Time frame: 16 weeks
Number of Participants Who Experienced a TEAE During the Apremilast Exposure Period
Time frame: 52 weeks
Number of Participants Who Experienced a Treatment-emergent Serious Adverse Event (TESAE) During the Placebo-controlled Phase
Time frame: 16 weeks
Number of Participants Who Experienced a TESAE During the Apremilast Exposure Period
Time frame: 52 weeks
Number of Participants Who Experienced a Treatment-related Adverse Event (TRAE) During the Placebo-controlled Phase
Time frame: 16 weeks
Number of Participants Who Experienced a TRAE During the Apremilast Exposure Period
Time frame: 52 weeks
Number of Participants With Diarrhea During the Placebo-controlled Phase
Time frame: Up to approximately 113 days
Number of Participants With Diarrhea During the Apremilast Exposure Period
Time frame: Day 1 up to approximately 365 days
Number of Participants With Diarrhea Symptoms During the Placebo-controlled Phase
Time frame: Up to approximately 113 days
Number of Participants With Diarrhea Symptoms During the Apremilast Exposure Period
Time frame: 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
Time frame: 16 weeks
Number of Participants With Suicidal Ideation or Behavior Per the C-SSRS During the Apremilast-extension Phase
Time frame: Week 16 to Week 52
Number of Female Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Time frame: Week 52
Number of Male Participants at Stage I-V of Sexual Development Per Tanner Staging of Sexual Development
Time frame: Week 52
Mean Body Weight of Participants During the Placebo-controlled Phase
Time frame: Baseline and Week 16
Mean Body Weight of Participants During the Apremilast Exposure Period
Time frame: Baseline and Week 52
Mean Height of Participants During the Placebo-controlled Phase
Time frame: Baseline and Week 16
Mean Height of Participants During the Apremilast Exposure Period
Time frame: Baseline and Week 52
Mean Body Mass Index (BMI) of Participants During the Placebo-controlled Phase
Time frame: Baseline and Week 16
Mean BMI of Participants During the Apremilast Exposure Period
Time frame: Baseline and Week 52
Number of Participants Who Experienced a Psoriasis Flare During the Placebo-controlled Phase
Time frame: 16 weeks
Number of Participants Who Experienced a Psoriasis Flare During the Apremilast Exposure Period
Time frame: 52 weeks
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38266683Fiorillo 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
99 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast (CC-10004) in people with Psoriasis, run by Amgen at 99 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, Russia, Spain, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Static Physician Global Assessment (sPGA) Response at Week 16 (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.