A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Sun Pharma

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Moderate-to-severe Chronic Plaque Psoriasis

Treatments: Drug: Tildrakizumab; Drug: Etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03997786

TILD-19-12

Details and patient eligibility

About

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)

Enrollment: 135 patients

Sex: All

Ages: 6 years to 215 months old

Volunteers: No Healthy Volunteers

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 and/or phototherapy.
• 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 Virus (HBV) test results, or hepatitis C virus (HCV) test result
• Subjects who have a high risk of suicidality at the Screening assessment as indicated by the C-SSRS (Columbia Suicide Severity Rating Scale), or based on the Investigator's judgment.
• Subject who has received any of the prohibited medications, supplements or substances during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 5 patient groups

Part A: Open-label PK and Safety: Part A

Active Comparator group

Description:

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

Treatment:

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Tildrakizumab

Part B- 1: Placebo and active comparator controlled study

Experimental group

Treatment:

Drug: Placebo

Drug: Etanercept

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Placebo

Drug: Tildrakizumab

Drug: Tildrakizumab

Part B-2: Randomized withdrawal and retreatment after relapse

Experimental group

Treatment:

Drug: Placebo

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Placebo

Drug: Tildrakizumab

Drug: Tildrakizumab

Part B 3: Efficacy and Safety Follow-up

No Intervention group

Part C: LTE

Experimental group

Treatment:

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Tildrakizumab

Drug: Tildrakizumab