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
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.