A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
Condition: Palmoplantaris Pustulosis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Apremilast; Placebo
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Palmoplantar Pustulosis; CC-10004; Apremilast; Only Japanese; Efficacy; Safety; Phase 2

Summary:

      This study will evaluate whether apremilast is better than placebo (inactive substance in the
      same form as the drug) for the treatment in Japanese subjects with PPP. This study also will
      evaluate the safety and tolerability of apremilast in Japanese subjects with
      PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel
      group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to
      treatment with topical steroid and/or topical vitamin D3 derivative preparations.

      The placebo-controlled period will be 16 weeks and patients will receive apremilast or
      placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast
      for 16 weeks. All subjects will have their final study visit 4 weeks after stopping
      apremilast treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic
             arthro-osteitis (PAO) for at least 24 weeks before screening.

          2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline.

          3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity
             score: ≥ 2) at screening and baseline.

          4. Subject has inadequate response to treatment with topical steroid and/or topical
             vitamin D3 derivative preparations prior to or at screening.

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          1. Subject has a diagnosis of plaque-type psoriasis.

          2. Subject has the presence of pustular psoriasis in any part of the body other than the
             palms and soles.

          3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement
             during the screening).

          4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental
             therapy) within 24 weeks of baseline.

          5. Subject has periodontitis obviously requiring treatment at screening.

          6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous
             treatment for a month or more at screening.

          7. Subject has evidence of skin conditions of hands and feet that would interfere with
             evaluations of the effect of study medication.

          8. Subject is pregnant or breastfeeding.