A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.
Condition: Parapsoriasis
MeSH terms: Psoriasis; Parapsoriasis
Intervention: Apremilast; Placebo; Placebo-Apremilast
Intervention description: Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.; Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.; At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)
Intervention MeSH terms: Thalidomide; 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: 221.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parapsoriasis; Plaque Psoriasis; CC-10004; Apremilast; Moderate Plaque Psoriasis; Safety

Summary:

      This study will evaluate the clinical efficacy, the patients quality of life, and safety of
      oral apremilast 30 mg twice daily (BID) compared to placebo, in adult patients with moderate
      plaque psoriasis during the 16 week Placebo controlled Phase and then upto 1 year in the
      Extension Phase of the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females, ≥ 18 years of age at the time of signing the informed consent
             document.

          2. Understand and voluntarily sign an informed consent document prior to any study
             related assessments/procedures being conducted.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the
             informed consent.

          5. Have moderate plaque psoriasis at screening and baseline as defined by

               1. BSA (Body Surface Area)5% to 10% and

               2. sPGA (Physician's Global Assessment) 3 (moderate) based on a 0 to 5 point scale

          6. Must be in general good health (except for psoriasis) as judged by the investigator,
             based on medical history, physical examination, and clinical laboratories.

          7. No prior exposure to systemic treatments or biologics for the treatment of psoriatic
             arthritis, psoriasis, or any other indication that could impact the assessment of
             psoriasis.

          8. 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 (IUD); 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.

          9. Male subjects (including those who have had a vasectomy) who engage in activity in
             which conception is possible must use barrier contraception (male latex condom or
             nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane])
             while on investigational product and for at least 28 days after the last dose of
             investigational product

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. 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, erythrodermic, guttate, inverse, or pustular psoriasis), other than
             plaque psoriasis.

          4. Prior history of suicide attempt at any time in the subject's life time prior to
             signing the informed consent and randomization, or major psychiatric illness requiring
             hospitalization within the last 3 years prior to signing the informed consent.

          5. Pregnant or breast feeding.

          6. Active substance abuse or a history of substance abuse within 6 months prior to
             signing the informed consent.

          7. Malignancy or history of malignancy, except for:

               1. treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;

               2. treated (ie, cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ
                  of the cervix with no evidence of recurrence within 5 years of signing the
                  informed consent.

          8. Topical therapy within 2 weeks of randomization (including, but not limited to,
             topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus,
             pimecrolimus, or anthralin/dithranol). Use of phototherapy within 4 weeks prior to
             randomization.

          9. Use of any investigational drug within 4 weeks prior to randomization, or 5
             pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

         10. Prolonged sun exposure or use of tanning booths, which may confound the ability to
             interpret data from the study.

         11. Prior treatment with apremilast.