Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.


Options:
A: Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months.
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.
* Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline.

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
* Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used the following therapies within 14 days of the first dose: topical calcineurin inhibitors including tacrolimus

  , topical vitamin A, activated form D3 or activated form D3 analogue preparations, weak through strong topical steroids (excluding application on the scalp, axillae, and groin)
* Subject has used the following therapies within 28 days of the first dose: any other systemic psoriasis therapy (eg, vitamin A, calcineurin inhibitors, methotrexates, steroids), UVA therapy (with or without psoralen), very strong or strongest topical steroid, tar therapy
* Subject has used the following therapies within 3 months of the first dose: adalimumab, etanercept, infliximab, or live vaccines
* Subject has used ustekinumab within 6 months of the first dose
* Subject has previously used an anti-interleukin-17 biologic therapy
B: Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
* Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject cannot avoid excessive sun exposure
* Subject is taking or requires oral or injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
C: Inclusion Criteria:

* Chronic plaque psoriasis for at least 6 months before baseline
* Failure, contraindication, or intolerability to at least 1 systemic therapy (including cyclosporine, methotrexate, or phototherapy)
* Psoriasis Area Severity Index (PASI) score at least 10 at screening and at baseline
* Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 15 weeks after stopping treatment

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks before baseline and during the study
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks of baseline, or have had topical psoriasis treatment within the 2 weeks of baseline
* Concurrent or recent use of any biologic agent within the following washout periods: etanercept \<28 days; infliximab, adalimumab, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; or any other biologic agent \<5 half-lives prior to baseline
* Have prior use of ustekinumab, or have any condition or contraindication to ustekinumab that would preclude the participant from participating in this protocol
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, have participated in any study investigating other interleukin (IL)-17 or IL-12/23 antagonists, or have received treatment with other IL-17 or IL-12/23 antagonists
* Have had a live vaccination within 12 weeks of baseline, or intend to have a live vaccination during the course of the study or within 15 weeks of completing treatment in this study
* Have had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months of baseline or intend to have vaccination with BCG during the course of the study or within 12 months of completing treatment in this study
* Have a known allergy or hypersensitivity to latex
* Have had any major surgery within 8 weeks of baseline or will require such during the study
* Have active or history of malignant disease within 5 years prior to baseline
* Significant uncontrolled disorder
* Ongoing infection or serious infection within 12 weeks of baseline; serious bone or joint infection within 24 weeks of baseline
* Are women who are lactating or breast-feeding
D: Inclusion Criteria:

* Have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator.
* Are a candidate for phototherapy and/or systemic therapy.
* Have both an Static Physician Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) score ≥12 at screening and at baseline.
* Have ≥10% body surface area (BSA) involvement at screening and baseline.
* If a male, agree to use a reliable method of birth control during the study.
* If female, agree to use highly effective method of contraception.

Exclusion Criteria:

* Predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis.
* Have a history of drug-induced psoriasis.
* Had a clinically significant flare of psoriasis during the 12 weeks before baseline.
* Use of tanning booths for at least 4 weeks before baseline.
* Concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept \<28 days; infliximab, adalimumab, certolizumab pegol, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent (e.g., ustekinumab) \<5 half lives.
* Have prior use of IL-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol.
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating IL-23p19 antagonists, or have received treatment with ixekizumab.
* Have previously failed to respond to an IL-17 antagonist, per investigator assessment.
* Have had a live vaccination within 12 weeks of baseline.
* Have a known allergy or hypersensitivity to any biologic therapy.
* Have had any major surgery within 8 weeks of baseline.
* Have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline.
* Are women who are pregnant, or who are lactating (breast-feeding).

Answer: C