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:

* Male or female patients with age ≥18 years at screening.
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):

  1. Have an involved body surface area (BSA) ≥10% and
  2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and
  3. Have a static Physician Global Assessment (sPGA) score of ≥3.
* Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
* Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.

Exclusion criteria:

* Patients with:

  1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
  2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment
* Previous exposure to BI 655066.
* Previous exposure to ustekinumab (Stelara®).
B: Inclusion Criteria:

* Present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline.
* Participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis.
* Have a (PASI score \>10 or BSA \>10) and DLQI \>10 at screening and at baseline.

Exclusion Criteria:

* Have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
* Have received systemic nonbiologic psoriasis therapy.
* Have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy.
* Have any condition or contraindication as addressed in the local labeling for MTX or FAE.
* Presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening.
* Have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer.
* Have had a serious infection or are immunocompromised.
* At screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.
C: Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
D: 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

Answer: D