Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris
Brief Summary: This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept.


Options:
A: Inclusion Criteria:

* Have been diagnosed with plaque psoriasis for at least 6 months.
* Have plaque psoriasis covering at least 15% of their total body.
* Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
* Be willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

* Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy.
* Subject is participating in another trial using an investigational agent or procedure.
* Women who are pregnant or breast-feeding or considering becoming pregnant.
B: Inclusion Criteria:

Key Inclusion Criteria for Healthy Subject Cohorts:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Key Inclusion Criteria for Psoriasis Subject Cohorts:

* Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive
* Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

Exclusion Criteria:

Key Exclusion Criteria for Healthy Subject Cohorts:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

Key Exclusion Criteria for Psoriasis Subject Cohorts:

* Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
* Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
C: Inclusion Criteria:

* Age 18 or older;
* Patient with moderate to severe plaque psoriasis for whom a decision to use etanercept has been made;
* At the investigator discretion, patient who would benefit from systemic therapy;
* PASI (psoriasis area and severity index) ≥ 10 and BSA (body surface area affected by psoriasis) ≥ 10 at day 0;
* Unless surgically sterile (or at least 1 year post-menopausal for women), abstinent or homosexual, patient (men and women) willing to use adequate contraceptive method for at least 30 days before Day 0 and until one month after the last drug administration;
* Patient capable of giving informed consent;
* Patient with normal or non clinically significant chest X ray within six months of screening;
* Patient with negative purified protein derivative (PPD) within 3 months of Day 0;
* Negative urine pregnancy test for women of childbearing potential

Exclusion Criteria:

* Patient used topical steroid, topical tar preparations, or other anti-psoriatic preparations except tar or salicylic acid shampoo or hydrocortisone for the face, scalp, genital and inframammary areas within two weeks of Day 0;
* Patient with presence of erythrodermic, pustular or a predominantly guttate psoriasis;
* At the investigator's discretion, patient with any significant infection within 30 days of screening or a patient at risk of septicemia;
* Patient with evidence of any skin condition that would interfere with the evaluation of psoriasis;
* Patient used investigational drugs within 12 weeks or three half-life of Day 0 whichever is longer;
* Patient used systemic anti-psoriatic drugs such as steroids, retinoids, methotrexate, cyclosporine within four weeks of Day 0;
* Patient used any biologic such as alefacept, etanercept, efalizumab, infliximab and adalimumab within 12 weeks of Day 0;
* Patient used ultraviolet light therapy (UVB or nbUVB) within four weeks of Day 0 or PUVA (psoralen ultra violet A) within eight weeks of Day 0;
* Patient with prior or concurrent use of cyclophosphamide;
* Patient with concurrent sulfasalazine therapy or concurrent use of anakinra;
* Patient with an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient.
* Uncontrolled or severe comorbidities such as diabetes mellitus requiring insulin; congestive heart failure (NYHA (New York Heart Association) class III or IV) or history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris; uncontrolled hypertension, oxygen-dependent severe pulmonary disease;
* Patient with a known sero-positivity for HIV (human immunodeficiency virus) or history of any other immunosuppressing disease;
* Patient with active or chronic hepatitis B or C;
* Patient with any active or chronic infection within four weeks before screening or between the screening and baseline visits;
* Patient with any mycobacterial disease, patient with a positive PPD, a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication;
* Patient with a known hypersensitivity to etanercept or one of its components or known to have antibodies to etanercept;
* Patient who received a live attenuated vaccines within 12 weeks of Day 0 or plan to receive one during the study;
* Current pregnancy or lactation;
* At the investigator's discretion, patient with current or history of alcohol or drug abuse that would interfere with the ability of the patient to comply with the study protocol;
* Patient with systemic lupus erythematosus or demyelinating disorder (optic neuritis, multiple sclerosis or other);
* Patient with a history of cancer within five years of Day 0 or presence of cancer except for treated basal or squamous cell carcinoma and in situ cervix carcinoma;
* Patient who failed to respond to nbUVB in the past;
* Patient who have a contra-indication to nbUVB;
* Patient with latex sensitivity (applicable only if they are using prefilled syringe or prefilled SureClickTM autoinjector presentations);
* Patient with a history of non-compliance with other therapies.
D: Inclusion Criteria:

1. Able and willing to give written informed consent.
2. Men or women is ≥18 and ≤ 75 years of age at time of screening.
3. Stable moderate to severe plaque psoriasis for at least 6 months before Screening.
4. Moderate to severe psoriasis as defined at Baseline by:

   BSA of ≥ 10% involvement at the Baseline visit. PGA score of ≥ 3 at the Baseline visit. PASI score of ≥ 12 at the Baseline visit.
5. Acceptable to systemic therapy, as judged by the investigator.
6. Previously received at least one traditional psoriasis treatment (for example, methotrexate, cyclosporine A, psoralen plus UVA or UVB, tretinoin, Chinese medicine, etc.), and was insensitive, intolerant, contraindicated to, or failed the treatment, as judged by the investigator.
7. At time of screening, lab tests have to meet the following:

   1. Hemoglobin ≥ 90 g/L
   2. WBC ≥ 3.5 × 10\^9/L
   3. Platelets ≥ 100 × 10\^9/L
   4. Serum creatinine ≤1.5 × upper limit of normal (ULN)
   5. AST and ALT ≤2 × ULN
8. For women of child-bearing age, a negative serum pregnancy test during screening, and a negative urine pregnancy test at baseline.
9. During the study to 150 days after the last dose of study medicine, subjects should use effective contraceptive measures
10. Subject is willing and able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

1. At screening visit, subjects with erythrodermic psoriasis, pustule psoriasis, bit type psoriasis, drug-induced psoriasis, other skin lesions (such as eczema), other systemic autoimmune inflammatory lesions, which may affect the efficacy evaluation of the treatment.
2. The subject has surgery plan during the study period (excluding surgery that is related to the study disease), except that there will be no increased risk for the subjects or no influence on the study treatment or adherence to the study as judged by the investigator.
3. Participants were given the following treatment, or will be required to receive the following treatment during the study period:

   1. The use of topical drugs within the first two weeks before screening;
   2. The use of UVA and/or UVB treatment, and non-biological drugs (such as methotrexate, cyclosporin, tretinoin, traditional Chinese medicine, proprietary Chinese medicine, etc) within the first four weeks before screening;
   3. In the first 4 weeks before screening, the use of Etanercept or Etanercept; in the first 12 weeks before screening, the use of other biological agents
4. Subjects had live vaccination in the first four weeks before screening, or have the intention to receive live vaccination during the study period.
5. Subjects with history of mycobacterium tuberculosis infection, or with active tuberculosis, or with latent tuberculosis, or with suspected tuberculosis infection judged by clinical phenotypes.
6. Anti-HIV antibody positive, or antibody positive for treponema pallidum, or anti-HCV antibody positive, or HBV HBsAg and/or HBcAb positive at screening.
7. Accompanying active infection or history:

   1. Within 4 weeks before screening, systemic anti-infection treatment;
   2. Within 8 weeks before screening, severe infection with hospitalization or intravenous anti-infection treatment;
   3. Recurrent, chronic, or other active infections, which may increase the study risk as evaluated by the investigator.
8. Known malignancy or history of malignancy (except for the following: in situ skin squamous carcinoma after thorough treatment with no sign of recurrence, basal cell carcinoma, cervical cancer in situ, or skin squamous carcinoma at least five years prior to randomization with no signs of recurrence after treatment).
9. Ongoing, severe, progressive, or uncontrolled diseases, including but not limited to diseases at the endocrine system, blood system, urinary system, liver and gallbladder, respiratory system, nervous system, cardiovascular system, gastrointestinal system or infectious diseases, with increased risk to participate the study as assessed by the investigator.
10. The subjects with active neuropathies, such as multiple sclerosis, Guillain-Barre Syndrome, optic neuritis, transverse myelitis, or neurological symptoms suggestive of the demyelinating diseases of the central nervous system.
11. Moderate to severe heart failure (NYHA III/IV)
12. History of allergic reactions to the active components of the study drugs (HLX03 and adalimumab (Humira®)) and their formulation gradients, or medicines belonging to the same pharmacology and biological category.
13. Participated in another study and received an experimental related drugs within the previous 3 months before screening.
14. Pregnant or lactating women.
15. History of alcohol or substance abuse or dependence, mental disorders.
16. Any condition that will lead to no treatment benefit or affect efficacy evaluation, as judged by the investigator.

Answer: C