| Eligibility |
Inclusion Criteria:
1. Men or women at least 18 years of age at time of screening.
2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before
randomization.
3. Moderate to severe psoriasis as defined at Baseline/ randomization by:
PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale
of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
4. Subject has moderate to severe chronic plaque-type psoriasis that is inadequately
controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
5. Body Mass Index (BMI) is 18 kg/m2 or above at screening
Exclusion Criteria:
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
guttate psoriasis) at Screening or Baseline/randomization.
2. Drug-induced psoriasis.
3. Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline
(Week 0).
4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that
in the judgement of the Investigator could interfere with assessment of psoriasis.
5. History of inflammatory bowel disease or have other ongoing active autoimmune
diseases.
6. At screening, history or symptoms of malignancy of any organ system, treated or
untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.
7. History of congestive heart failure (New York Heart Association [NYHA] functional
classification =III), cerebro-cardiovascular events, or serious bleeding events at
screening and / or randomization that in the judgement of the Investigator prevents
the subject from participating in the study.
8. Active systemic infections (other than common cold) during the 4 weeks before
randomization (e.g., hepatitis), or serious infections requiring hospitalization
and/or intravenous injection of antibiotic treatment within eight weeks prior
torandomization.
9. History of depression and/or suicidal ideation or any suicidal behavior based on an
assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and
baseline (Posner K et al, 2011), The subjects will be exluded if any answer to
question is "yes" in the questionnaire orare clinically judged by the investigator to
be at risk for suicide.
10. All subjects will be tested for tuberculosis status using IGRA and X-ray test.
11. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human
immunodeficiency virus (HIV) antibodies.
12. Have a known allergy or hypersensitivity to any biologic therapy at screening that
would pose an unacceptable risk to the subject if participating in this study.
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