A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Study Purpose

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)

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 Pharmaceutical Industries Limited
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	Hungary, India, Poland, Slovakia, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Moderate-to-severe Chronic Plaque Psoriasis

Arms & Interventions

Arms

Active Comparator: Part A

Part A is a DOSE FINDING COMPONENT: OPEN LABEL PK lead-in and safety component

Experimental: Part B Part 1: Placebo and active comparator controlled study

Experimental: Part B-1 and B-2: Randomized withdrawal and retreatment after relapse

No Intervention: Part B 3: Efficacy and Safety Follow-up

Experimental: Part C: LTE

Interventions

Drug: - Tildrakizumab

Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)

Drug: - Placebo

(Weeks 0 to 16)

Drug: - Tildrakizumab

(Weeks 16 to 52)

Drug: - Tildrakizumab

at every 12 weeks in open label fashion till 5 years (240 weeks).

Drug: - Tildrakizumab

(Weeks 0 to 16)

Drug: - Etanercept

(Weeks 0 to 16)

Drug: - Placebo

(Weeks 16 to 52)

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.

Site 23, Birmingham, Alabama

Status

Withdrawn

Address

Site 23

Birmingham, Alabama, 35244

Site Contact

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