Plaque PsoriasisPhase 3NCT06088199
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
A Phase 3 study testing Apremilast in people with Plaque Psoriasis, run by Amgen at 30 sites in United States.
Trial summary
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 30 sitesUnited States
- Study dates
- 24 Oct 2023to 12 Aug 2026
- 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
- Participants must have a weight of ≥ 20 kg.
- Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents.
- Participant is able to swallow the study medication tablet.
- Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
- Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
- Psoriasis Area Severity Index score 2-15,
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- Body surface area 2-15%, and
- Static Physician Global Assessment score of 2-3 (mild to moderate)
- Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
Who cannot join
- Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
- Psoriasis flare or rebound within 4 weeks prior to screening.
- Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
- History of recurrent significant infections.
- Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
- Any history of or active malignancy or myeloproliferative or lymphoproliferative disease.
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- Current use of the following therapies that may have a possible effect on psoriasis:
- Conventional systemic therapy for psoriasis within 28 days prior to Study Day 1 (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters).
- Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day 1.
- Biologic therapy:
- Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
- Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
- Other TNF or IL-17 blockers (such as infliximab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to Study Day 1
- Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1.
- Use of tanning booths or other ultraviolet light sources.
- Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
- Female participant of childbearing potential with a positive pregnancy test assessed at screening and/or Study Day 1 by a serum and/or urine pregnancy test.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Great Lakes Research Group Inc- Sheffield
Bay City, Michigan, 48706
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29425
Pediatric Skin Research LLC
Coral Gables, Florida, 33146
Studies in Dermatology LLC
Cypress, Texas, 77429
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202
Empire Dermatology
East Syracuse, New York, 13057
Johnson Dermatology Clinic
Fort Smith, Arkansas, 72916
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Avance Clinical Trials
Laguna Niguel, California, 92677
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, 64064
State University of New York, Downstate Medical Center
Manhasset, New York, 11030
Ciocca Dermatology
Miami, Florida, 33173
Frontier Derm Partners
Mill Creek, Washington, 98012
Boeson Research
Missoula, Montana, 59804
Southern Indiana Clinical Trials
New Albany, Indiana, 47150
OptiSkin Medical
New York, New York, 10029
Hightower Clinical LLC
Oklahoma City, Oklahoma, 73120
University of California Irvine
Orange, California, 92868
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Oregon Health and Science University
Portland, Oregon, 97239
MedDerm Associates
San Diego, California, 92103
Clinical Science Institute
Santa Monica, California, 90404
Affiliated Dermatology
Scottsdale, Arizona, 85255
Clear Dermatology
Scottsdale, Arizona, 85255
Endeavor Health Clinical Trials Center
Skokie, Illinois, 60077
Stride Clinical Research LLC
Sugar Land, Texas, 77479
University of South Florida
Tampa, Florida, 33612
California Dermatology Institute
Thousand Oaks, California, 91320
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, 74132
About this study
Official title: A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Apremilast
- Keywords
- Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called AMG 407, Otezla, CC-10004
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events
Measured: Day 1 up to approximately 285 days
Secondary outcomes (10)
Growth and Development as Assessed by Height
Measured: Day 1 up to approximately 285 days
Growth and Development as Assessed by Weight
Measured: Day 1 up to approximately 285 days
Growth and Development as Assessed by Body Mass Index (BMI)
Measured: Day 1 up to approximately 285 days
Columbia-Suicide Severity rating Scale (C-SSRS)
Measured: Day 1 to Day 225
Tanner Staging of Sexual Maturity
Measured: Day 1 and Day 225
Number of Participants With Psoriasis Flare
Measured: Up to approximately 285 days
Number of Participants With Psoriasis Rebound
Measured: Up to approximately 285 days
Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
Measured: Day 1 to Day 225
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Measured: Up to approximately 225 days
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: Up to approximately 285 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start24 Oct 2023
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- 51 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
- NCT06088199
- Sponsor's protocol ID
- 20200196
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Participants From 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06088199
- Acronym / sponsor ID
- 20200196
- Conditions
- Plaque Psoriasis
- Keywords
- Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 18 Oct 2023 (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.
The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastApremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Participants must have a weight of ≥ 20 kg.
- Participant must have an age and sex specific BMI value no lower in range than the fifth percentile on the growth chart for children and adolescents.
- Participant is able to swallow the study medication tablet.
- Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
- Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
Key exclusion criteria (17 listed)
- Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
- Psoriasis flare or rebound within 4 weeks prior to screening.
- Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
- History of recurrent significant infections.
- Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
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: AMG 407, Otezla, CC-10004Oral tablet | Drug | Apremilast |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 up to approximately 285 days
10 secondary outcomes
Growth and Development as Assessed by Height
Time frame: Day 1 up to approximately 285 days
Growth and Development as Assessed by Weight
Time frame: Day 1 up to approximately 285 days
Growth and Development as Assessed by Body Mass Index (BMI)
Time frame: Day 1 up to approximately 285 days
Columbia-Suicide Severity rating Scale (C-SSRS)
Time frame: Day 1 to Day 225
Tanner Staging of Sexual Maturity
Time frame: Day 1 and Day 225
Number of Participants With Psoriasis Flare
Time frame: Up to approximately 285 days
Number of Participants With Psoriasis Rebound
Time frame: Up to approximately 285 days
Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries
Time frame: Day 1 to Day 225
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: Up to approximately 225 days
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 285 days
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 23 Oct 2026.
- 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
30 sites in 1 country: 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 Plaque Psoriasis, run by Amgen at 30 sites in United States.
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 17 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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?
Number of Participants With Treatment-emergent Adverse Events (time frame: Day 1 up to approximately 285 days). 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 23 Oct 2026.