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Active, not recruiting Phase 2/3

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

NCT03997786 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2/3
Started
2020-01-15
Last updated
2026-04-15

Condition(s) studied

Moderate-to-severe Chronic Plaque Psoriasis

Investigational drug(s) / intervention(s)

Tildrakizumab →PlaceboTildrakizumab →Tildrakizumab →Tildrakizumab →Etanercept →Placebo

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

Sex
ALL
Min age
6 Years
Max age
215 Months
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03997786 on ClinicalTrials.gov ↗ ← All trials in Spain