Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Secukinumab on Aortic Vascular Inflammation and Cardiometabolic Biomarkers After 12 Weeks of Treatment, Compared to Placebo, and up to 52 Weeks of Treatment With Secukinumab in Adult Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Brief Summary: This study evaluated the effect of secukinumab compared to placebo on aortic vascular inflammation in adult patients who have moderate to severe plaque psoriasis that is poorly controlled by current psoriasis treatments.


Options:
A: Inclusion Criteria Common to Both Part A:

* Participant must have active plaque psoriasis covering at least 10% body surface area and a PASI score of at least 12 at screening and at randomization.
* Participant is a candidate for systemic therapy
* Participant has a Static Physician's Global Assessment (sPGA) score of at least 3 at screening and at randomization

Inclusion Criterion Specific to Part B

* Participant has completed the treatment period for part A (at least through week 20)

Inclusion Criterion Specific to Part C

* Participant has completed the treatment period for part B

Exclusion Criteria Common to Part A, B and C:

* Participant has pustular, erythrodermic and/or guttate forms of psoriasis
* Participant has had a clinically significant flare of psoriasis during the 12 weeks prior to study entry
* Participant has recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept \>28 days, infliximab or adalimumab \>56 days, alefacept \>60 days, ustekinumab \>8 months, or any other biologic agent/monoclonal antibody \>5 half-lives prior to baseline
* Participant has received systemic psoriasis therapy (such as psoralen and ultraviolet A \[PUVA\] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 \[mild, such as desonide\] or 7 \[least potent, such as hydrocortisone\] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia)
* Participant has donated more than 500 mL of blood within the last month
* Participant has another serious disorder or illness
* Participant has suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months
* Participant has a history of uncontrolled high blood pressure
* Participant has clinical laboratory test results at entry that are outside the normal reference range
* Participant is currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
* Participant is a woman who is lactating or breast feeding
* If a participant is a woman and could become pregnant during this study, she must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study
* If a participant is post menopausal woman, she must be at least 45 years of age and have not menstruated for the last 12 months
* If a participant is a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, she must have an additional blood test to see if you can participate
* If the participant is male, he must agree to reduce the risk of female partner becoming pregnant during the study

Exclusion Criteria Specific to B:

* If a participant experienced a serious adverse event during Part A considered possibly related to ixekizumab
* If a participant experienced an adverse event during Part A that the study doctor believes continued ixekizumab treatment could cause harm to the participant.

Exclusion Criteria Specific to C:

* If a participant experienced a Serious Adverse Event during Part B considered possibly related to ixekizumab
* If a participant experienced an adverse event during Part B that the study doctor believes continued ixekizumab treatment could cause harm to the participant.
B: Inclusion Criteria:

* Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
* In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
* Negative urine pregnancy test before the first dose of study drug in all female patients

Exclusion Criteria:

* Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
* Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
* Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.
C: Inclusion Criteria:

Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).

* Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
* Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
* Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
* Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
* Subjects on MTX must be on folic acid supplementation at randomization.
* Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
* Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
* Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

Exclusion Criteria:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics.

* Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
* Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
* Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
* Other protocol-defined exclusion criteria do apply
D: Inclusion Criteria:

- Males and females at least 18 years of age with moderate to severe plaque psoriasis

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque psoriasis
* Previous exposure to IL-17A or IL-17 receptor targeting agents.
* Other active or ongoing disease that may interfere with evaluation of psoriasis or places the patient at unacceptable risk
* Other protocol-defined inclusion/exclusion criteria may apply

Answer: D