A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Study Purpose

The study has been designed with two components. Part A is an open label PK study followed by a randomized trial component (Part B). 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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 215 Months
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03997786
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sun Pharma Global FZE
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate-to-severe Chronic Plaque Psoriasis
Arms & Interventions

Arms

Placebo Comparator: Part B - Placebo

Active Comparator: Part B - Etanercept

Experimental: Tildrakizumab

Interventions

Drug: - Tildrakizumab

Part A: Pediatric subjects with a body weight in the highest category will be treated with the same dose as adult subjects (e.g. 100 mg for patients weighing >40 kg). Lower doses will be selected with the aim to achieve tildrakizumab plasma exposures in the clinically relevant range across all body weight(BW) categories (e.g. subjects weighing 15 -40 kg, will be given 2.5 mg/kg BW). Part B: Subcutaneous injection of tildrakizumab will be administered at Weeks 0 and 4

Drug: - Placebo - tildrakizumab

Subcutaneous injection of placebo will be administered at Weeks 0 and 4

Drug: - Etanercept

Etanercept will be administered at 0.8mg/kg (for subjects <63kg) and 50 mg (for subjects weighing >63kg body weight) weekly for 12 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

SPARC Site 1, Fountain Valley, California

Status

Recruiting

Address

SPARC Site 1

Fountain Valley, California, 92708

SPARC Site 2, Thousand Oaks, California

Status

Recruiting

Address

SPARC Site 2

Thousand Oaks, California, 91320

SPARC Site 3, Boca Raton, Florida

Status

Recruiting

Address

SPARC Site 3

Boca Raton, Florida, 33021

SPARC Site 6, Miami, Florida

Status

Not yet recruiting

Address

SPARC Site 6

Miami, Florida, 33173

SPARC Site 4, Tampa, Florida

Status

Recruiting

Address

SPARC Site 4

Tampa, Florida, 33609

SPARC Site 8, Portland, Oregon

Status

Not yet recruiting

Address

SPARC Site 8

Portland, Oregon, 97223

SPARC Site 8, West Jordan, Utah

Status

Not yet recruiting

Address

SPARC Site 8

West Jordan, Utah, 84088

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