A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.

This is a Phase 4, multicenter, randomized, placebo-controlled, double-blind study of the
efficacy and safety of apremilast in subjects with moderate plaque psoriasis. 221
participants were randomized 2 (apremilast):1 (placebo) at approximately 25 sites in the
United States. Those randomized to the apremilast treatment group received apremilast 30 mg
tablets orally twice daily for 52 weeks. Those randomized to the placebo treatment group
received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally
twice daily (BID) for 16 weeks. Beginning Week 16, those initially randomized to placebo were
switched to receive apremilast 30 mg BID for an additional 36 weeks (52 weeks total).

Study enrolled adult patients with stable moderate plaque psoriasis, who are naïve to
systemic psoriasis treatments.

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.