Plaque Psoriasis
Conditions
Keywords
Apremilast, Otezla, AMG 407, CC-10004, Pediatric, Plaque psoriasis
Brief 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.
Interventions
DRUGApremilast
Oral tablet
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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, * 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events | Day 1 up to approximately 285 days |
Secondary
| Measure | Time frame |
|---|---|
| Growth and Development as Assessed by Height | Day 1 up to approximately 285 days |
| Growth and Development as Assessed by Weight | Day 1 up to approximately 285 days |
| Growth and Development as Assessed by Body Mass Index (BMI) | Day 1 up to approximately 285 days |
| Columbia-Suicide Severity rating Scale (C-SSRS) | Day 1 to Day 225 |
| Tanner Staging of Sexual Maturity | Day 1 and Day 225 |
| Number of Participants With Psoriasis Flare | Up to approximately 285 days |
| Number of Participants With Psoriasis Rebound | Up to approximately 285 days |
| Number of Participants Experiencing Diarrhea Sympotms as Assessed by Stool Diaries | Day 1 to Day 225 |
| Number of Participants with Clinically Significant Changes in Laboratory Parameters | Up to approximately 225 days |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to approximately 285 days |
Countries
United States
Contacts
STUDY_DIRECTORMD
Amgen
Outcome results
None listed