A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Drug: Apremilast
Oral tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-emergent Adverse Events [Day 1 up to approximately 285 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants must have a weight of ≥ 20 kg.
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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.
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Participant is able to swallow the study medication tablet.
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Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
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Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by:
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Psoriasis Area Severity Index score 2-15,
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Body surface area 2-15%, and
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Static Physician Global Assessment score of 2-3 (mild to moderate)
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Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
Exclusion Criteria:
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Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
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Psoriasis flare or rebound within 4 weeks prior to screening.
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Active tuberculosis (TB) or a history of incompletely treated TB per local guidelines.
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History of recurrent significant infections.
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Active infection or infection treated with antibiotic treatment within 14 days of Study Day 1.
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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:
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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).
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Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 28 days prior to Study Day 1.
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Biologic therapy:
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Etanercept (or biosimilar) treatment 28 days prior to Study Day 1
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Adalimumab (or biosimilar) treatment 10 weeks prior to Study Day 1
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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
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Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab, guselkumab, or tildrakizumab) within 24 weeks prior to Study Day 1.
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Use of tanning booths or other ultraviolet light sources.
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Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during screening or at Study Day 1.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20200196