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

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.