Apremilast in Palmo-Plantar Psoriasis
Condition: Palmo-plantar Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Placebo
Intervention description: Apremilast tablets will be provided to sites in blister cards.
Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at the Day 0 and week 16 visits (refer to section 6.1). Following the 6 day titration period (for Day 0 and week 16) blister packs will contain apremilast 30 mg bid or placebo bid.; Placebo tablets will be provided to sites in blister cards.
Intervention MeSH terms: Apremilast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: moderate to severe non-pustular palmo-plantar psoriasis

Summary:

      This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects
      with moderate to severe plaque psoriasis involving palms and/or soles.

      Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared
      against placebo (dummy drug with no active ingredient).

      This study will enroll approximately 100 adult subjects with moderate to severe plaque
      psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be
      eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles,
      with lesions covering at least 10% of the surface of palms and soles at the baseline visit.
      Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning
      that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first
      16 weeks. Subjects will not know which of the two treatments they receive. The study doctor,
      the study staff will not know which treatment they receive either. All subjects will receive
      Apremilast from Week 16 to Week 32.

      Subjects will be asked to complete questionnaires about their hand and feet pain, their
      quality of life, their general health and the impact of psoriasis on their work.

      Medical photographs of palms and soles will be taken for subjects at selected study sites
      only.

      At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies
      can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or
      certain cellular messengers that can be quantified. It is also possible to study the skin
      cellular structure and organization.

      A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or
      soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit,
      only one biopsy from psoriasis on palms or soles will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient, male or female, is aged 18 years or older at the screening visit.

          2. Patient has a history of plaque psoriasis involving the palm(s) and/or sole(s) for at
             least 6 month(s).

          3. Patient has moderate to severe psoriasis with a PPPGA of at least 3 and with at least
             10% of the total surface of palms and soles (PPPSA) affected by psoriatic plaques at
             baseline.

        Exclusion Criteria:

          1. Female patient is pregnant or breastfeeding

          2. Patient has the presence of pustules on palms or soles at screening or baseline

          3. Patient who has used any topical treatment for psoriasis (except non-medicated
             emollients) in the last 14 days before Day 0 with the exception of hydrocortisone and
             desonide for the face, groin (including genitals) and inframammary areas as well as
             shampoos containing tar, salicylic acid or zinc pyrithione if they are applied with
             gloves.

          4. Patient who has used ultraviolet B (UVB) phototherapy or excessive sun exposure less
             than 28 days before Day 0.

          5. Patient has used any non-biological systemic therapy for the treatment of psoriasis
             (including psoralens ultraviolet A (PUVA)) therapy, methotrexate, acitretin and
             cyclosporin), systemic steroids or systemic immunosuppressants less than 28 days
             before Day 0.

          6. Use of any investigational agents within 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

          7. Prior treatment with apremilast

          8. Patient is currently participating in a clinical trial with an experimental agent or
             device.

          9. Patient is using or has used any biological therapy for the treatment of psoriasis.
             Exceptions to this criterion are: patients who used no more than one biologic in the
             past and stopped for reasons other than lack of efficacy are eligible.

         10. Patient is taking or requires oral or injectable corticosteroids during the study.
             Inhaled corticosteroids for stable medical conditions are allowed. Patients who have
             used oral or injectable corticosteroids less than 28 days before Day 0 are excluded.

         11. Patient is known to have immune deficiency or is immunocompromised or currently uses
             or plans to use anti-retroviral therapy at any time during the study.

         12. Active tuberculosis or history of inadequately treated tuberculosis

         13. Other than psoriasis, patient has any clinically significant (as determined by the
             Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic,
             renal, hematologic, immunologic disease, or other major disease that is currently
             uncontrolled.

         14. Other than psoriasis, patient has any other dermatological condition that could, in
             the opinion of the investigator, interfere with the study assessments.

         15. Any condition, including the presence of laboratory abnormalities (including estimated
             creatinine clearance of less than 30 mL per minute), which would place the patient at
             unacceptable risk if he/she were to participate in the study.

         16. Malignancy or history of malignancy, except for:

               -  treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;

               -  treated [ie, cured] malignancy with no evidence of recurrence within the previous
                  5 years.

         17. Known hypersensitivity to apremilast or any excipients in formulation.

         18. Patient has the following hereditary disease: galactose intolerance, Lapp lactase
             deficiency or glucose-galactose malabsorption

         19. Use of strong cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital,
             carbamazepine, phenytoin)

         20. Active substance abuse or a history of substance abuse within 6 months prior to
             Screening.

         21. Prior history of suicide attempt at any time in the patient's life time prior to
             screening or randomization, or major psychiatric illness requiring hospitalization
             within the last 3 years.

         22. Presence of uncontrolled depression.