A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Apremilast; Topical Therapy
Intervention description: Tablets for oral administration; Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.
Intervention MeSH terms: Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the efficacy and safety of the combination of
      apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have
      not achieved an adequate response with topicals alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy the following criteria to be enrolled in the study:

          1. Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF)
             with plaque psoriasis.

          2. Subject has understood and voluntarily signed an informed consent document prior to
             any study related assessments/procedures being conducted.

          3. Subject is able to adhere to the study visit schedule and other protocol requirements.

          4. Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior
             to Baseline.

          5. Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.

          6. Subject is currently treated for psoriasis with topical therapies only for at least 4
             weeks prior to Baseline.

          7. Subject has inadequate response to current topical therapy as per Investigator's
             discretion.

          8. Subject is naïve to all biologic therapies for psoriasis vulgaris.

          9. Subject must be in general good health (except for psoriasis) as judged by the
             Investigator, based on medical history, physical examination, and clinical
             laboratories.

             (NOTE: The definition of good health means a subject does not have uncontrolled
             significant co-morbid conditions).

         10. Subjects that are females of childbearing potential (FCBP) must have a negative
             pregnancy test at Screening and Baseline. While on investigational product and for at
             least 28 days after taking the last dose of investigational product, FCBP who engage
             in activity in which conception is possible must use one of the approved contraceptive
             options described below:

        Option 1: Any one of the following highly effective methods: hormonal contraception (oral,
        injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation;
        or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom
        NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional
        barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c)
        contraceptive sponge with spermicide.

        Exclusion Criteria:

        The presence of any of the following will exclude a subject from enrollment:

          1. Subject has any condition, including other inflammatory diseases or dermatologic
             conditions, which confounds the ability to interpret data from the study, including
             other types of psoriasis (ie, pustular, inverse, erythrodermic, or guttate), other
             than plaque psoriasis.

          2. Subject has psoriatic arthritis that requires systemic therapy.

          3. Subject has history of drug-induced psoriasis.

          4. Subject has had prior treatment with biologic therapies for psoriasis.

          5. Subject has used phototherapy or conventional systemic therapy for psoriasis within 8
             weeks prior to baseline and during the study (including but not limited to
             cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate,
             thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine).

          6. Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from
             Screening to Baseline.

          7. Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8
             weeks prior to Baseline and during the study.

          8. Subject is currently enrolled in any other clinical trial involving an investigational
             product.

          9. Subject has other than psoriasis, 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.

         10. Subject has malignancy or history of malignancy or myeloproliferative or
             lymphoproliferative disease within the past 3 years, except for treated (ie, cured)
             basal cell or squamous cell in situ skin carcinomas.

         11. Subject has received a live vaccine within 3 months of baseline or plans to do so
             during study.

         12. Subject is pregnant or breastfeeding (lactating) women.

         13. Subject has bacterial infections requiring treatment with oral or injectable
             antibiotics, or significant viral or fungal infections, within 4 weeks of Screening.
             Any treatment for such infections must have been completed and the infection cured, at
             least 4 weeks prior to Screening and no new or recurrent infections prior to the
             Baseline Visit.

         14. Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive
             at screening.

         15. Subject is positive for antibodies to hepatitis C at screening.

         16. Subject has any condition, including the presence of laboratory abnormalities, which
             would place the subject at unacceptable risk if he/she were to participate in the
             study.

         17. Subject has prior history of suicide attempt at any time in the subject's life time
             prior to signing the informed consent and enrollment, or major psychiatric illness
             requiring hospitalization within the last 3 years prior to signing the informed
             consent.

         18. Subject has active substance abuse or a history of substance abuse within 6 months
             prior to signing the informed consent.

         19. Subject has prior treatment with apremilast or participation in a clinical study
             involving apremilast.