Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis
Condition: Psoriasis-Type Psoriasis; Plaque-Type Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast
Intervention description: 20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID.
Intervention MeSH terms: Apremilast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Apremilast,; Psoriasis,; PASI-75,; sPGA

Summary:

      The study will test the safety and tolerability of Apremilast twice a day in participants
      with recalcitrant plaque type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

        Must understand and voluntarily sign an informed consent form

          -  Must be male or female subject of any ethnic origin or race that is >18 years at time
             of consent

          -  Must have a documented history of plaque-type psoriasis for at least 6 months prior to
             screening visit

          -  Subjects must fulfill criteria outlined in at least one of the following clinical
             categories:

               -  Unresponsive to standard systemic therapy, as defined by clinical history, in the
                  investigator's opinion, i.e. inadequate response to one or more adequate
                  treatment course (s) of standard systemic therapy

               -  Intolerant to or cannot receive (e.g., contraindication to prescribe) standard
                  systemic therapy or biological interventions for psoriasis

          -  Must have a Static Physician Global Assessment (sPGA) score of at least 3 and a Body
             surface area (BSA) ≥ 10% at screening

          -  Must meet the specified laboratory criteria:

             o Must be able to adhere to the study visit schedule and study protocol requirements

          -  Females of childbearing potential (FCBP) must have a negative urine pregnancy test at
             screening (Visit 1). In addition, FCBP must agree to use two of the following adequate
             forms of contraception methods such as oral, injectable, or implantable hormonal
             contraception; tubal ligation; intrauterine device; barrier contraceptive with
             spermicide or vasectomized partner while on study. A FCBP must agree to have pregnancy
             tests every 4 weeks while on study medication.

          -  Males (including those who have had a vasectomy) must agree to use barrier
             contraception (latex condoms) when engaging in sexual activity with FCBP

        Exclusion Criteria:

          -  History of clinically significant (as determined by the investigator) cardiac,
             endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
             immunologic, or other major disease

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study

          -  Pregnant or lactating females

          -  History of active tuberculosis (TB) infection within 3 years prior to the screening
             visit. Infections which occurred > 3 years prior to entry must have been effectively
             treated

          -  History of incompletely treated latent (as indicated by a positive PPD [purified
             protein derivative] skin results) TB infection

          -  Clinically significant abnormality on the chest x-ray (CXR) at screening

          -  Psoriasis flare within 30 days of screening, as defined by protocol

          -  Use of systemic therapy for psoriasis within 28 days of Visit 2 (Baseline).

          -  Topical therapy as defined in the protocol Adalimumab, etanercept, efalizumab or
             infliximab use within 56 days of Visit 2 (Baseline)

          -  Alefacept use within 180 days of Visit 2 (Baseline)

          -  Phototherapy Ultraviolet light A (UVA), Ultraviolet light B (UVB), Psoralens and
             long-wave ultraviolet radiation (PUVA) within 28 days of Visit 2 (Baseline)

          -  Use of any investigational drug within 28 days of Visit 2 (Baseline), or 5 half lives
             if known (whichever is longer) Clinically significant abnormality on 12-lead
             Electrocardiogram (ECG) at screening