Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study of Single and Multiple Dose Regimens With Subcutaneous CNTO 1275 (Human Monoclonal Antibody to IL-12) in Subjects With Moderate to Severe Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of initial single and multiple subcutaneous injections of CNTO 1275 in the treatment of patients with moderate to severe plaque psoriasis.


Options:
A: Inclusion Criteria:

* Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[BSA\] involvement, "moderate" or greater score on the Physician's Global Assessment \[PGA\] scale, and PASI score ≥12 at Baseline)
* Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study

Exclusion Criteria:

* Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Participants who will require oral or injectable corticosteroids during the trial
* Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
* Participants with evidence of active or untreated latent tuberculosis (TB) according to Screening criteria specified in the protocol. (Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to treatment with study medication)
* Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
* Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.
B: Inclusion Criteria for cases:

* past or current treatement with TNF-a antagonists
* either lymphoma severe bacterial infection opportunistic infection

Inclusion Criteria for controls:

* matched with cases by gender, age (+/- 5 years), underlying disease (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, or psoriasis)
* past or current treatement with TNF-a antagonists
* no lymphoma, severe bacterial infection, opportunistic infection (same as case)

Exclusion Criteria:

* none
C: 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)
D: Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without \[Psoriatic Arthritis\]PsA) for at least 6 months before the first administration of study drug
* A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
* Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
* Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has previously received guselkumab or secukinumab
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
* Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
* Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins

Answer: C