PsoriasisPhase 3NCT04175613
A Long-term Extension 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 in people with Psoriasis, run by Amgen at 50 sites in 9 countries.
Trial summary
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 50 sitesin 9 countries
- Study dates
- 20 Dec 2019to 12 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subject must satisfy the following criteria to be enrolled in the study:
- Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
- Subject must have a weight of ≥ 20 kg.
- Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
- Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
- Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
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- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- All female subjects of childbearing potential (FCBP) must either practice abstinence from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first.
- At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.
- Females of childbearing potential must have a negative pregnancy test at each visit. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy;
- OR
- Option 2: Male or female condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method:
- diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- NOTE: Option 2 may not be acceptable as a contraception option in all countries per local guidelines/regulations.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
- Subject has a condition that confounds the ability to interpret data from the study.
- Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
- Subject is pregnant or breastfeeding.
- Subject has guttate, erythrodermic, or pustular psoriasis.
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- Subject has active tuberculosis (TB) or a history of incompletely treated TB.
- Subject answers "Yes" to any question on the Columbia-Suicide Severity Rating Scale at Visit 16 of study CC-10004-PPSO-003.
- Subject plans concurrent use of the following therapies that may have a possible effect on psoriasis.
- Conventional systemic therapy for psoriasis (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
- Biologic therapy:
- Etanercept (or biosimilar) treatment ii. Adalimumab (or biosimilar) treatment iii. Other TNF or interleukin (IL)-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) c) Use of any investigational drug other than apremilast
- Subject has prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.
- Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Trial locations and contacts
50 sites in 9 countries.
50 sites in 9 countries
Russia14 sites
Altai State Medical University
Barnaul, 656038
Chelyabinsk Regional Clinical Skin and Venereal Dispensary
Chelyabinsk, 454048
Republican Clinical Dermatology and Venerology Dispensary
Kazan', 420012
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
Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology
Moscow, 119071
National Medical Research Center for Children Health
Moscow, 119991
LLC Medical Center Zdorovaya Semiya
Novosibirsk, 630099
Pierre Wolkenshtein Skin Diseases Clinic LLC
Saint Petersburg, 191123
Saint Petersburg State Pediatric Medical University
Saint Petersburg, 194100
LLC PiterKlinika
Saint Petersburg, 196158
Bashkiria State Medical University
Ufa, 450083
Yarosavl State Medical Academy
Yaroslavl, 150000
Ural Scientific Research Institute of Dermatovenereology and Immunopathology
Yekaterinburg, 620076
United States13 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Wright State Physicians
Fairborn, Ohio, 45324
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
Dawes Fretzin Dermatology Group Inc
Indianapolis, Indiana, 46256
First OC Dermatology
Irvine, California, 92697
Solutions Through Advanced Research Inc
Jacksonville, Florida, 32256
Skin Care Physicians of Georgia
Macon, Georgia, 31217
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53715-1375
Ciocca Dermatology
Miami, Florida, 33173
Stanford University School of Medicine
Palo Alto, California, 94304
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Driscoll Childrens Hospital
San Antonio, Texas, 78218
California Dermatology Institute
Thousand Oaks, California, 91320
Spain8 sites
General University Hospital of Alicante
Alicante, 3010
Hopsital Germans Trias I Pujol
Badalona, 08916
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
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
Hospital Marques de Valdecilla
Santander, 39008
Canada4 sites
Stollery Childrens Hospital
Edmonton, Alberta, T6G 2B7
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1C 2H5
AvantDerm
Toronto, Ontario, M5A 3R6
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2
Belgium3 sites
Centre Hospitalier Universitaire Saint Pierre
Brussels, 1000
Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
Italy3 sites
Azienda Ospedaliero Universitaria Di Cagliari
Cagliari, 09124
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera di Padova
Padova, 35020
Czechia2 sites
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Synexus Czech sro
Prague, 120 00
France2 sites
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, 13500
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, 31400
About this study
Official title: A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
- Conditions
- Psoriasis
- Being tested
- Apremilast
- Keywords
- Plaque Psoriasis, CC-10004, Apremilast, Pediatric, Age 6 - 17 years
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called CC-10004, Otezla
Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Apremilast | Experimental | Subjects with a weight between 20 kg to < 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: Up to approximately 4 years
Columbia-Suicide Severity Rating Scale (C-SSRS)
Questionnaire to monitor depression, suicidal thoughts and behavior
Measured: Collected at each study visit throughout the life of the study - up to 4 years
Weight of patients treated with Apremilast
Body weight in kg
Measured: Collected at each study visit throughout the life of the study - up to 4 years
Mean body mass index of the patient treated with Apremilast
BMI (combined outcome of weight and height in the form of kg/m^2)
Measured: Collected at each study visit throughout the life of the study - up to 4 years
Height patients treated with Apremilast
Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
Measured: Collected at each study visit throughout the life of the study - up to 4 years
Assessment of sexual maturity
Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
Measured: Collected every 52 weeks throughout the life of the study - up to 4 years
Secondary outcomes (1)
Static Physician Global Assessment (sPGA)
is the assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation.
Measured: Collected at each study visit throughout the life of the study - up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Dec 2019
- Primary completion30 Oct 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT04175613
- Sponsor's protocol ID
- CC-10004-PPSO-004
- Other IDs
- U1111-1242-3537, 2019-003497-13, 2019
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04175613
- Acronym / sponsor ID
- CC-10004-PPSO-004
- Conditions
- Psoriasis
- Keywords
- Plaque Psoriasis, CC-10004, Apremilast, Pediatric, Age 6 - 17 years
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.
The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Apremilast | Experimental | Drug: ApremilastSubjects with a weight between 20 kg to < 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
- Subject must have a weight of ≥ 20 kg.
- Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
- Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
- Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
Key exclusion criteria (14 listed)
- Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
- Subject has a condition that confounds the ability to interpret data from the study.
- Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
- Subject is pregnant or breastfeeding.
- Subject has guttate, erythrodermic, or pustular 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 |
|---|---|---|
| ApremilastAlso: CC-10004, OtezlaApremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study | Drug | Patients treated with Apremilast |
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately 4 years
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Questionnaire to monitor depression, suicidal thoughts and behavior
Weight of patients treated with Apremilast
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Body weight in kg
Mean body mass index of the patient treated with Apremilast
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
BMI (combined outcome of weight and height in the form of kg/m^2)
Height patients treated with Apremilast
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Height (inches or centimeters) will be collected for all pediatric subjects and descriptively summarized
Assessment of sexual maturity
Time frame: Collected every 52 weeks throughout the life of the study - up to 4 years
Sexual maturation, assessed by Tanner staging system, will be conducted for all pediatric subjects and descriptively summarized
1 secondary outcome
Static Physician Global Assessment (sPGA)
Time frame: Collected at each study visit throughout the life of the study - up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- 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
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Psoriasis, run by Amgen at 50 sites in 9 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 15 inclusion and 14 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Russia, United States, Spain, Canada, Belgium and 4 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (AEs) (time frame: Up to approximately 4 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.