Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)
Brief Summary: This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of participants achieving \>= Psoriasis Area Sensitivity Index of 75% (PASI-75) response and the proportion of participants with a Physician's Global Assessment (PGA) score of "clear" or "minimal" with at least a 2 grade reduction from baseline at Week 12.


Options:
A: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Plaque psoriasis for at least 6 months
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy

Exclusion Criteria:

* Other forms of psoriasis
* History of recent infection
* Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria apply
B: Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following 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 Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* Rheumatoid factor and anti-CCP antibodies negative at screening
* Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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.

Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

* Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
* 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. The following wash out periods need to be observed:
* Oral or topical retinoids 4 weeks
* Photochemotherapy (e.g. PUVA) 4 weeks
* Phototherapy (UVA or UVB) 2 weeks
* Topical skin treatments (except in face, scalp and genital area during screening, only corticosteroids with mild to moderate potency) 2 weeks
* 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 (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
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:

* Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
* Candidate for phototherapy or systemic therapy;
* Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
* For the extension study: must have completed Part 3 of the base study
* For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study

Exclusion Criteria:

* Non-plaque forms of psoriasis
* Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
* Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
* Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
* Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
* Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17 antagonists
* Latex allergy or sensitivity
* Active or untreated latent tuberculosis (TB)
* For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or are breast feeding
* For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
* For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study

Answer: D