Melanoma Clinical Trial

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Summary

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)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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, 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.

Exclusion Criteria:

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) ≥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
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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT03997786

Recruitment Status:

Recruiting

Sponsor:

Sun Pharmaceutical Industries Limited

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There are 49 Locations for this study

See Locations Near You

Site 23
Birmingham Alabama, 35244, United States
Site 1
Fountain Valley California, 92708, United States More Info
Site 2
Thousand Oaks California, 91320, United States More Info
Site 4
Clearwater Florida, 33756, United States
Site 24
Coral Gables Florida, 33146, United States
Site 20
Miami Florida, 33126, United States
Site 7
Miami Florida, 33173, United States More Info
Site 12
Orlando Florida, 32819, United States
Site 5
Bay City Michigan, 48706, United States
Site 16
Troy Michigan, 48084, United States
Site 22
Saint Joseph Missouri, 64506, United States
Site 8
Dallas Texas, 75231, United States
Site 10
South Jordan Utah, 84095, United States
Site 14
Spokane Washington, 99202, United States
Site 63
Budapest , H-103, Hungary
Site 62
Budapest , H-103, Hungary
Site 61
Debrecen , H-403, Hungary
Site 64
Kaposvar , H-740, Hungary
Site 28
Szeged , 6720, Hungary
Site 79
Ahmedabad , 38000, India
Site 70
Ahmedabad , 38001, India
Site 78
Chennai , 60000, India
Site 75
Kolkata , 70005, India
Site 76
Kolkata , 70007, India
Site 71
Lucknow , 22600, India
Site 73
Pune , 41100, India
Site 74
Surat , 39500, India
Site 77
Surat , 39501, India
Site 80
Warangal , 50600, India
Site 57
Bialystok , 15-45, Poland
Site 55
Gdańsk , 80-21, Poland
Site 51
Katowice , 40-61, Poland
Site 54
Lodz , 90-26, Poland
Site 56
Lodz , 90-43, Poland
Site 58
Lublin , 20-57, Poland
Site 50
Ostrowiec Swietokrzyski , 27-40, Poland
Site 59
Sosnowiec , 41-20, Poland
Site 52
Szczecin , 70-33, Poland
Site 53
Warszawa , 02-50, Poland
Site 40
Wrocław , 50-56, Poland
Site 39
Wrocław , 51-50, Poland More Info
Site 38
Wrocław , 51-68, Poland More Info
Site 92
Bardejov , 8501, Slovakia
Site 91
Svidnik , 8901, Slovakia
Site 90
Trnava , 91775, Slovakia
Site 41
Barcelona , 08041, Spain More Info
Site 47
Las Palmas De Gran Canaria , 35019, Spain More Info
Site 42
Madrid , 28041, Spain
Site 44
Valencia , 46014, Spain
Site 45
Valencia , 46940, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT03997786

Recruitment Status:

Recruiting

Sponsor:


Sun Pharmaceutical Industries Limited

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