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:

* 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
* Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
* No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.

Exclusion Criteria:

* Non-plaque or drug induced forms of psoriasis;
* Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
* Any uncontrolled significant medical condition.
B: 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
C: Inclusion Criteria:

* Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment.

Exclusion Criteria:

* Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis.
* Systemic or topical treatments for psoriasis other than emollients. Ongoing bacterial, viral or fungal infections.

History or presence of malignancy.

* Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.
D: Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis.
* Subject has any active CTCAE grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids
* Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies
* Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines
* Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose
* Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab

Answer: B