A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Purpose
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.
Condition
- Plaque Psoriasis
Eligibility
- Eligible Ages
- Between 6 Years and 17 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Apremilast |
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. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
More Details
- Status
- Recruiting
- Sponsor
- Amgen