Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast (CC-10004); Placebo
Intervention description: Apremilast (CC-10004); Placebo
Intervention MeSH terms: Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric; 6 through 17 years; Plaque Psoriasis; Psoriasis; CC-10004; Apremilast; Otezla; Children; Adolescents; SPROUT

Summary:

      This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the
      efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe
      plaque psoriasis.

      At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive
      either apremilast or placebo for the first 16 weeks and then all subjects will receive
      apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to
      apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17
      years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg
      BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and
      efficacy of apremilast in the treatment of pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed
             consent form is signed by the legal guardian

          2. Subjects must have a weight of ≥ 20 kg

          3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening.

          4. Has moderate to severe plaque psoriasis at Screening and Baseline as defined by:

               -  PASI score ≥ 12; and

               -  Body surface area (BSA) ≥ 10%; and

               -  sPGA ≥ 3 (moderate to severe)

          5. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis

          6. Candidate for systemic therapy or phototherapy

        Exclusion Criteria:

          1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline

          2. Psoriasis flare or rebound within 4 weeks prior to Screening

          3. Prior history of suicide attempt at any time in the subject's lifetime prior to
             Screening or randomization in the study, or major psychiatric illness requiring
             hospitalization within 3 years prior to signing the assent and informed consent

          4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during
             Screening or at Baseline

          5. Current or planned concurrent use of the following therapies that may have a possible
             effect on psoriasis

             a. Topical therapy within 2 weeks prior to randomization (including but not limited to
             topical corticosteroids, topical retinoid or vitamin D analog preparations,
             tacrolimus, pimecrolimus, or anthralin/dithranol)

             Exceptions*:

             i. Low potency or weak corticosteroids (please refer to the Investigators' Manual)
             will be allowed as background therapy for treatment of the face, axillae and groin in
             accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg,
             Eucerin®) will also be permitted for body lesions

             *Subjects should not use these topical treatments within 24 hours prior to the clinic
             visit.

             b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization
             c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to
             randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD
             half-lives (whichever is longer).