Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Mild to Moderate Plaque Psoriasis
Brief Summary: This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.

Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.


Options:
A: Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF).
2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF.
3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline.
4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline.
5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
6. Subject must meet laboratory criteria.
7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
2. Subjects 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.

2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB.

4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease).

5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening.

6. Subject has prior history of suicide attempt at any time in the subject's life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial.

8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

9. Subject had prior treatment with apremilast.
B: Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis at least 6 months
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of 12 or greater
* Considered by treating dermatologist to be a candidate for phototherapy or systemic treatment of psoriasis
* Women of childbearing potential and all men must agree to use adequate birth control measures
* Have no history of latent or active tuberculosis

Exclusion Criteria:

* Currently have nonplaque forms of psoriasis or drug-induced psoriasis
* Women who are pregnant or nursing, or men and women planning pregnancy while enrolled in the study
* Patients who have a history of chronic or recurrent infectious disease or who have or have had a serious infection requiring hospitalization or intravenous antibiotics within the previous 2 months
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C
* Patients who have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
C: Inclusion Criteria:

* Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
* Have moderate-to-severe psoriasis in the genital area at screening and baseline.
* Have plaque psoriasis in a nongenital area at screening and baseline.
* Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
* Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis.
* History of drug-induced psoriasis.
* Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
* Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
* Are currently enrolled in any other clinical trial involving an investigational product.
* Serious disorder or illness other than plaque psoriasis.
* Active or history of malignant disease within 5 years prior to baseline.
* Serious infection within the last 3 months.
* Have received a live vaccine within 3 months of baseline or plan to do so during the study.
* Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
* Pregnant or breastfeeding (lactating) women.
D: Inclusion Criteria:

* Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
* A target plaque of at least 9 sq. cm.

Exclusion Criteria:

* Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
* Non plaque form of psoriasis;
* Currently have or history of psoriatic arthritis;
* Current drug induced psoriasis;
* Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
* Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

Answer: A