A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Inclusion Criteria:

• Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, mustweight greater than or equal to 15Kg.

• Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subjectinterview and confirmation of diagnosis through physical examination byinvestigator).

• Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score ≥ 3, and PASI score ≥ 12

• Subject must be considered a candidate for systemic therapy, meaning psoriasisinadequately controlled by topical treatments (corticosteroids), and/orphototherapy, and/or previous systemic therapy

• Subject is considered to be eligible according to tuberculosis (TB) screeningcriteria

• A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if thefirst is indeterminate; the result of the second test will then be used.

Exclusion Criteria:

• Subject has predominantly non-plaque forms of psoriasis specifically erythrodermicpsoriasis, predominantly pustular psoriasis, medication-induced ormedication-exacerbated psoriasis, or new-onset guttate psoriasis

• Subject has laboratory abnormalities at screening including any of the following:Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit ofnormal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5mg/dL, white blood cell count < 3.0 x 103/μL, and any other laboratory abnormality,which, in the opinion of the Investigator, will prevent the subject from completingthe study or will interfere with the interpretation of the study results

• Subject who is expected to require topical therapy, phototherapy, or additionalsystemic therapy for psoriasis during the trial

• Female subjects of childbearing potential who are pregnant, intend to becomepregnant (within 6 months of completing the trial), or are lactating. (Sexuallyactive adolescent girls will be required to use contraception)

• Subject with presence of any infection or history of recurrent infection requiringtreatment with systemic antibiotics within 2 weeks prior to Screening, or severeinfection (e.g. pneumonia, cellulitis, bone or joint infections) requiringhospitalization or treatment with IV antibiotics within 8 weeks prior to Screening

• Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS)antigen, or hepatitis C virus (HCV) test result