Melanoma Clinical Trial
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)
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 â‰¥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 â‰¥ 3, and PASI score â‰¥ 12
Subject must be considered a candidate for systemic therapy, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
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.
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 has laboratory abnormalities at screening including any of the following: Alanine transaminase (ALT) or aspartate transaminase, (AST) â‰¥2X the upper limit of normal, Creatinine â‰¥1.5X the upper limit of normal serum direct bilirubin â‰¥ 1.5 mg/dL, white blood cell count < 3.0 x 103/Î¼L, 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
Subject who is expected to require topical therapy, phototherapy, or additional systemic therapy for psoriasis during the trial
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)
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
Positive human immunodeficiency virus (HIV) test result, hepatitis B surface (HBS) antigen, or hepatitis C virus (HCV) test result
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There are 49 Locations for this study
Birmingham Alabama, 35244, United States
Clearwater Florida, 33756, United States
Coral Gables Florida, 33146, United States
Miami Florida, 33126, United States
Orlando Florida, 32819, United States
Bay City Michigan, 48706, United States
Troy Michigan, 48084, United States
Saint Joseph Missouri, 64506, United States
Dallas Texas, 75231, United States
South Jordan Utah, 84095, United States
Spokane Washington, 99202, United States
Budapest , H-103, Hungary
Budapest , H-103, Hungary
Debrecen , H-403, Hungary
Kaposvar , H-740, Hungary
Szeged , 6720, Hungary
Ahmedabad , 38000, India
Ahmedabad , 38001, India
Chennai , 60000, India
Kolkata , 70005, India
Kolkata , 70007, India
Lucknow , 22600, India
Pune , 41100, India
Surat , 39500, India
Surat , 39501, India
Warangal , 50600, India
Bialystok , 15-45, Poland
GdaÅ„sk , 80-21, Poland
Katowice , 40-61, Poland
Lodz , 90-26, Poland
Lodz , 90-43, Poland
Lublin , 20-57, Poland
Ostrowiec Swietokrzyski , 27-40, Poland
Sosnowiec , 41-20, Poland
Szczecin , 70-33, Poland
Warszawa , 02-50, Poland
Bardejov , 8501, Slovakia
Svidnik , 8901, Slovakia
Trnava , 91775, Slovakia
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