Active, not recruiting
Phase 2/3
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
Condition(s) studied
Moderate-to-severe Chronic Plaque Psoriasis
Investigational drug(s) / intervention(s)
TildrakizumabPlaceboTildrakizumabTildrakizumabTildrakizumabEtanerceptPlacebo
Tildrakizumab: Week 0 (Day 1), Week 4 (Day 28) and week 16 (Day 112)
Placebo: (Weeks 0 to 16)
Tildrakizumab: (Weeks 16 to 52)
Tildrakizumab: at every 12 weeks in open label fashion till 5 years (240 weeks).
Tildrakizumab: (Weeks 0 to 16)
Etanercept: (Weeks 0 to 16)
Placebo: (Weeks 16 to 52)
Study 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)
Eligibility
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.
Primary outcome measure(s)
- Part A - Dose determination for pediatrics population 12 to <18-year-old age group — Up to week 16
- Part A - Dose determination for pediatrics population 6 to <12 year-old age group — Up to week 16
- Proportion of subjects with at least 75% improvement in the PASI response from baseline — Week 16
- Proportion of subjects with PGA score of "clear" or "minimal" with at least a 2-grade reduction from baseline — Week 16
- Number of subjects with adverse events — Week 16
Trial sites (27)
| Facility | City | Region | Status |
| Site 1 |
Fountain Valley |
California |
|
| Site 2 |
Thousand Oaks |
California |
|
| Site 20 |
Miami |
Florida |
|
| Site 7 |
Miami |
Florida |
|
| Site 14 |
Spokane |
Washington |
|
| Site 63 |
Budapest |
Hungary |
|
| Site 62 |
Budapest |
Hungary |
|
| Site 61 |
Debrecen |
Hungary |
|
| Site 64 |
Kaposvár |
Hungary |
|
| Site 79 |
Ahmedabad |
India |
|
| Site 71 |
Lucknow |
India |
|
| Site 74 |
Surat |
India |
|
| Site 57 |
Bialystok |
Poland |
|
| Site 51 |
Katowice |
Poland |
|
| Site 54 |
Lodz |
Poland |
|
| Site 56 |
Lodz |
Poland |
|
| Site 58 |
Lublin |
Poland |
|
| Site 50 |
Ostrowiec Świętokrzyski |
Poland |
|
| Site 59 |
Sosnowiec |
Poland |
|
| Site 52 |
Szczecin |
Poland |
|
| Site 53 |
Warsaw |
Poland |
|
| Site 39 |
Wroclaw |
Poland |
|
| Site 92 |
Bardejov |
Slovakia |
|
| Site 91 |
Svidník |
Slovakia |
|
| Site 90 |
Trnava |
Slovakia |
|
| Site 41 |
Barcelona |
Spain |
|
| Site 47 |
Las Palmas de Gran Canaria |
Spain |
|