A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Korábbi kezelés

• Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis
• Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
• Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening
• Subject who has received any of the prohibited medications, supplements or substances during the study.

Más betegség

• Positive human immunodeficiency virus (HIV) test result, hepatitis B Virus (HBV) test results, or hepatitis C virus (HCV) test result

Laborértékek

• Subject has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) ≥2X the upper limit of normal, Creatinine ≥1.5X the upper limit of normal serum direct bilirubin ≥ 1.5 mg/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 completing the study or will interfere with the interpretation of the study results

Egyéb

• Female subjects of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. (Sexually active adolescent girls will be required to use contraception)
• Subjects who have a high risk of suicidality at the Screening assessment as indicated by the C-SSRS (Columbia Suicide Severity Rating Scale), or based on the Investigator's judgment.

• Subject must be 6 to \< 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg.
• Diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator).
• 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 and/or phototherapy.
• Subject is considered to be eligible according to tuberculosis (TB) screening criteria
• A maximum of 2 QuantiFERON tests will be allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used.