A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque
      psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK
      of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of
      apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area
      Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global
      Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a
      total of 107 weeks which includes screening, treatment (including the PK portion of the study
      and the extension treatment period), two short-term follow-up periods and a long-term
      follow-up period.
    

Detailed description: 
      Each subject will undergo a screening period of up to 5 weeks, a treatment period of 2 weeks
      with PK sample collection, and an extension treatment period of 48 weeks, to allow subjects
      access to apremilast treatment if medically appropriate (following the completion of the 2
      week PK portion). Regardless of when they stop treatment, subjects should complete two post
      treatment follow-up visits at approximately 4 and 8 weeks after the last dose. All subjects
      should complete the final follow-up visit at Week 102 or at a timepoint 52 weeks after the
      last dose of apremilast was taken in subjects who have withdrawn at any time prior to Week
      50. At least 32 subjects will be enrolled into this study to provide an adequate PK profile
      and safety assessment in subjects of different ages and body weight ranges. Subjects will be
      divided into 2 age groups (adolescents [ages 12 to 17 years, inclusive] and children [ages 6
      to 11 years, inclusive]), with at least 16 subjects in each group. Apremilast treatment will
      start in older and heavier subjects.

      Group 1 (ages 12 to 17 years, inclusive; weight ≥ 35 kg)

        -  The data collected from the first 8 subjects will be reviewed by an independent data
           monitoring committee (DMC) to determine if it is appropriate to proceed with dosing the
           balance of Group 1 subjects and to proceed with dosing in the Group 2 subjects.

      and an evaluation of these data by the DMC has been completed.

      Group 2 (ages 6 to 11 years, inclusive; weight ≥ 15 kg)

        -  The dose regimens (dose strength and/or dose frequency) for these first 8 subjects will
           be based upon the PK and safety assessments from the first 8 subjects in Group 1.

        -  For the remaining subjects in Group 2, the dose (dose strength and/or dose frequency)
           will be based upon the subject weight as determined by the PK and safety assessments.
           The dose strength and/or dose frequency will be adjusted for any safety concerns or for
           unexpected changes in exposure. In the event of a dose regimen adjustment after the
           second PK and safety assessment, the first 8 subjects in Group 2 will return to the site
           for the appropriate dosing adjustment.
    

Intervention name(s): Apremilast
Intervention type(s): Drug
Other intervention name(s): CC-10004
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psoriasis; Moderate to Severe Plaque Psoriasis; Plaque Psoriasis; CC-10004; Apremilast; Pharmacokinetics; Open-label; Safety; Pediatric