Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Inclusion Criteria:

1. Male and female subjects between 18 and 75 years of age.
2. Moderate to severe plaque-type psoriasis for at least 6 months.
3. Subject is a candidate for systemic biologic therapy.
4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
5. Subject is able to comply with the study procedures.
6. Subject must provide informed consent.

Exclusion Criteria (Main):

1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
2. Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
3. Laboratory abnormalities at screening, as defined in the study protocol.
4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
6. History of suicidal thoughts within 12 months.
B: 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.
C: Inclusion Criteria:

* Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
* 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 randomization
* 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
D: Inclusion Criteria:

* Age 18 or older;
* Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept has been made;
* At the investigator discretion, patient who would benefit from systemic therapy;
* PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by psoriasis) ≥ 10 at day 0;
* Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or homosexual, patient (men and women) willing to use adequate contraceptive method for at least 30 days before Day 0 and until one month after the last drug administration;
* Patient capable of giving informed consent;
* Patient with normal or non clinically significant chest X ray within six months of screening;
* Patient with negative purified protein derivative (PPD) within 3 months of Day 0;
* Negative urine pregnancy test for women of childbearing potential

Exclusion Criteria:

* Patient used topical steroid, topical tar preparations, or other anti-psoriatic preparations except tar or salicylic acid shampoo or hydrocortisone for the face, scalp, genital and inframammary areas within two weeks of Day 0;
* Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;
* At the investigator's discretion, patient with any significant infection within 30 days of screening or a patient at risk of septicemia;
* Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
* Patient used investigational drugs within 12 weeks or three half-life of Day 0 whichever is longer;
* Patient used systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within four weeks of Day 0;
* Patient used any biologic such as alefacept, etanercept, efalizumab, infliximab and adalimumab within 12 weeks of Day 0;
* Patient used ultraviolet light therapy (UVB or nbUVB) within four weeks of Day 0 or PUVA (psoralen ultra violet A) within eight weeks of Day 0;
* Patient with prior or concurrent use of cyclophosphamide;
* Patient with concurrent sulfasalazine therapy or concurrent use of anakinra;
* Patient with an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient.
* Uncontrolled or severe comorbidities such as diabetes mellitus requiring insulin; congestive heart failure (NYHA (New York Heart Association) class III or IV) or history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris; uncontrolled hypertension, oxygen-dependent severe pulmonary disease;
* Patient with a known sero-positivity for HIV (human immunodeficiency virus) or history of any other immunosuppressing disease;
* Patient with active or chronic hepatitis B or C;
* Patient with any active or chronic infection within four weeks before screening or between the screening and baseline visits;
* Patient with any mycobacterial disease, patient with a positive PPD, a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
* Patient with a known hypersensitivity to etanercept or one of its components or known to have antibodies to etanercept;
* Patient who received a live attenuated vaccines within 12 weeks of Day 0 or plan to receive one during the study;
* Current pregnancy or lactation;
* At the investigator's discretion, patient with current or history of alcohol or drug abuse that would interfere with the ability of the patient to comply with the study protocol;
* Patient with systemic lupus erythematosus or demyelinating disorder (optic neuritis, multiple sclerosis or other);
* Patient with a history of cancer within five years of Day 0 or presence of cancer except for treated basal or squamous cell carcinoma and in situ cervix carcinoma;
* Patient who failed to respond to nbUVB in the past;
* Patient who have a contra-indication to nbUVB;
* Patient with latex sensitivity (applicable only if they are using prefilled syringe or prefilled SureClickTM autoinjector presentations);
* Patient with a history of non-compliance with other therapies.

Answer: C