RECRUITING

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis

Quick Facts

Study Start:2020-01-15

Study Completion:2031-12-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03997786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 215 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Head, Clinical Development

CONTACT

91 2266455645

Clinical.Trial@sunpharma.com

Study Locations (Sites)

Site 23

Birmingham, Alabama, 35244

United States

Site 1

Fountain Valley, California, 92708

United States

Site 2

Thousand Oaks, California, 91320

United States

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

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

Collaborators and Investigators

Sponsor: Sun Pharmaceutical Industries Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-15

Study Completion Date2031-12-05

Study Record Updates

Study Start Date2020-01-15

Study Completion Date2031-12-05

Terms related to this study

Additional Relevant MeSH Terms

Moderate-to-severe Chronic Plaque Psoriasis