A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT06088199

20200196

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Apremilast

Experimental group

Description:

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.

Treatment:

Drug: Apremilast