Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Brief Summary: The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.


Options:
A: Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
* Severity of psoriasis disease meeting all of the following three criteria:
* Psoriasis Area and Severity Index (PASI) score of 12 or greater,
* Investigator's Global Assessment (IGA) score of 3 or greater,
* Total body surface area (BSA) affected of 10% or greater.
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.
* Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.
B: Inclusion Criteria:

* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic plaque psoriasis for at least 6 months prior to first dose of study drug
* At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at first dose of study drug
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Prior use of etanercept
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
C: Inclusion Criteria:

* Understand and voluntarily sign an informed consent form
* ≥18 years of age at the time of signing the informed consent form
* Able to adhere to the study visit schedule and other protocol requirements.
* Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:

  1. PASI (Psoriasis Area and Severity Index) score ≥ 12
  2. Body Surface Area (BSA) ≥ 10%
* Candidate for photo/systemic therapy
* In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis
* Meet all laboratory criteria as defined per protocol
* Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication
* Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication

Exclusion Criteria:

* History of clinically significant disease (as determined by the investigator)
* Pregnant or breastfeeding
* History of active mycobacterial infection within 3 years
* History of Human Immunodeficiency Virus (HIV) infection
* Congenital and acquired immunodeficiencies
* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
* Antibodies to Hepatitis C at screening
* Malignancy or history of malignancy except for treated \[i.e., cured\] basal-cell skin carcinomas
* Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Psoriasis flare within 4 weeks of screening
* Topical therapy within 2 weeks of randomization
* Systemic therapy for psoriasis within 4 weeks of randomization
* Use of phototherapy within 4 weeks of randomization \[(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)\]
* Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization
* Alefacept within 24 weeks of randomization
* Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)
* Prolonged sun exposure or use of tanning booths or other ultraviolet light sources
D: Inclusion Criteria:

* Plaque-type psoriasis diagnosed \>= 6 months prior
* Plaque-type psoriasis covering at least 10% of total body surface areas
* Psoriasis area-and-severity index score of \>=12 at screening and baseline
* 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 throughout the trials and for 12 months following the last injection of study agent
* Have no history of latent or active tuberculosis (TB)

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 used any therapeutic agent targeted at reducing IL-12 or IL-23
* Patients who have had a Bacillus Calmette-Guerin (BCG) vaccination within the previous 12 months prior to screening
* 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 prior to screening
* Patients who have or ever have had a nontuberculous mycobacterial infection or opportunistic infection
* Patients known to be infected with human immunodeficiency virus (HIV), 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
* Patients with a malignancy or who have a history of malignancy (with the exception of certain skin cancers and pre-invasive cervical cancer)
* Patients participating in another trial using an investigational agent or procedure
* Systemic immunosuppressants within 4 weeks of the first administration of study agent

Answer: C