Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vascular Inflammation in Psoriasis - Extension Study
Brief Summary: VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.


Options:
A: Inclusion criteria:

* Male or female patients. Women of childbearing potential\* must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

  \*Women of childbearing potential are defined as:
  * having experienced menarche and are
  * not postmenopausal (12 months with no menses without an alternative medical cause) and are
  * not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
* 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.Duration of diagnosis may be reported by the patient,
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization):

  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.
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practices (GCP) and local legislation

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,
* Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study (participation in observational studies is permitted),
* Previous exposure to ustekinumab (Stelara®),
* Use of any restricted medication, or any drug considered likely to interfere with the safe conduct of the study,
* Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, aneurysm removal, stomach ligation),
* Known chronic or relevant acute infections including active tuberculosis, HIV or viral hepatitis; QuantiFERON® tuberculosis (TB) test or purified protein derivative (PPD) skin test will be performed according to local labelling for comparator products. If the result is positive, patients may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment should have been initiated and maintained according to local country guidelines,
* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix,
* Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram \[ECG\]), or laboratory value at the screening visit outside the reference range that is in the opinion of the investigator, is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data,
* History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients,
* Women who is pregnant, nursing, or who plans to become pregnant while in the trial,
* Previous enrolment in this trial.
B: Inclusion Criteria:

1. Males and females 18 years of age and older.
2. Subject completed the VIP Study
3. Subject willing and able to avoid prolonged exposure of skin affected by psoriasis to natural or sunlight or tanning beds during the course of the study
4. Subject is willing and able to avoid topical or systemic prescription treatments for psoriasis besides adalimumab during the course of the study
5. Women are eligible to participate in the study if they meet one of the following criteria:

   1. Women of childbearing potential must undergo pregnancy testing during the baseline visit and agree to use one of the following methods of contraception throughout the 13-month study:

      * Oral contraceptives;
      * Transdermal contraceptives
      * Injectable or implantable methods
      * Intrauterine devices
      * Barrier methods (for example but not limited to a diaphragm with spermicide, condom with spermicide); or
      * Vasectomized partner
      * Subjects using oral or parental forms of contraceptives must have been using those methods of birth control for at least three months prior to the baseline visit.
   2. Women who have undergone tubal ligation
   3. Women who are postmenopausal (for at least one year), sterile, or hysterectomized are eligible to participate
   4. Women who agree to be sexually abstinent, defined as total abstinence from sexual intercourse, as a form of contraception are eligible to participate in the study.
6. Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, and physical examination.
7. Able and willing to give written informed consent and to comply with requirements of this study protocol.

Exclusion Criteria:

1. Previous adverse event following exposure to a TNF-alpha antagonist that led to discontinuation of the TNF inhibitor and contraindicates future treatment.
2. Previous lack of response to a TNF-alpha antagonist led to discontinuation.
3. Diagnosis of erythrodermic psoriasis, generalized pustular psoriasis, or medication-induced or medication-exacerbated psoriasis.
4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of psoriasis.
5. Subject is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
6. Poorly controlled medical condition, such as unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents, psychiatric disease requiring frequent hospitalization, and any other condition, which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
7. History of diabetes mellitus, type 1 or type 2 (patients with type 2 diabetes may be enrolled if the duration of diabetes is \<10 years and HbA1c is \<7.0%)
8. Uncontrolled hypertension, with measured systolic blood pressure \>180 mmHg or diastolic blood pressure \>90 mmHg
9. History of demyelinating diseases or lupus.
10. Subject has infection or risk factors for severe infections, for example:

    * Known history of HIV, hepatitis B or C, or other severe, recurrent, or persistent infections;
    * Excessive immunosuppression or other factors associated with it, including human immunodeficiency virus infection;
    * Active tuberculosis (TB) disease;
    * Evidence of latent TB infection demonstrated by Purified Protein Derivative (PPD) ≥ 5 mm of induration or positive Quantiferon-GOLD results as determined within 6 months of the baseline visit for VIP-E; except if prophylactic treatment for TB, as recommended by local guidelines, is initiated prior to administration of study drug or if there is documentation that the subject has received prophylactic treatment for TB previously.
    * Any other significant infection requiring hospitalization or intravenous (IV) antibiotics in the month prior to Baseline;
    * Infection requiring treatment with oral or parenteral antibiotics within 14 days prior to Baseline;
    * Subject will require a live vaccination during study participation including up to 30 days after the last dose of study drug.
11. Subject has history of hematological or solid malignancy within the past five years other than successfully treated basal cell carcinoma, non-metastatic cutaneous squamous cell carcinoma or cervical carcinoma in situ.
12. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
13. Clinic laboratory analyses showing any of the following abnormal results:

    * Hemoglobin (Hgb) \< 10 g/dL in females or \<12 g/dL in males;
    * White blood cell (WBC) count \<2.5 x 109/L

      * Subject can be included if WBC count is \<2.5 x x 109/L and absolute neutrophil count (ANC) is \>1000 cells / mm3.
    * WBC count \> 15 x 109/L;
    * Platelet count \< 100 x 109/L;
    * Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>2.5 upper limits of normal (ULN);
    * Serum total bilirubin ≥2 mg/dL (≥26 µmol/L)
14. Recent history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
15. If subject is on cholesterol-lowering medication (e.g. statin), dose and form of medication must be stable for 90 days prior to baseline and remain stable throughout the duration of the study.
C: Inclusion Criteria:

* Subjects must give a written, signed and dated informed consent
* Chronic plaque-type psoriasis present for at least 6 months before randomization
* Moderate to severe plaque psoriasis as defined at randomization by:

  * PASI score of ≥12 and
  * Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
  * IGA mod 2011 ≥3 (based on a scale of 0-4)
* Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:

  * Topical treatment (including topical corticosteroids) and/or
  * Phototherapy and/or
  * Previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than plaque psoriasis
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
* Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
D: Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile

Answer: B