A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

NCT03997786 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TILD-19-12
• Study Type: interventional
• Target: 135
• Locations: 6 countries
• Sites: 27

Brief 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)

Conditions

Moderate-to-severe Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (12)

• Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 50 from baseline

  Week 12, 16, 28, 40, 52, 64, 76 and 88

• Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 90 from baseline

  Week 12, 16, 28, 40, 52, 64, 76 and 88

• Proportion of subjects achieving Psoriasis Area & Severity Index (PASI) 100 from baseline

  Week 12, 16, 28, 40, 52, 64, 76 and 88

• Proportion of subjects achieving PASI 75 and PGA score of "clear" or "almost clear" with at least a 2 grade reduction from baseline

  Week 16, 28, 40, 52, 64, 76 and 88

• Change in quality of life as measured by Children's Dermatology Life Quality Index (CDLQI)

  Week 108

Other Outcomes (6)

• Relapse rates after withdrawal of treatment with tildrakizumab

  Week 52

• Rebound rates after withdrawal of treatment with tildrakizumab

  Week 52

• response to retreatment after relapse after withdrawal of treatment with tildrakizumab - Proportion of subjects with at least 75% improvement in the PASI response from baseline

  Week 52

Study Arms (5)

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

ACTIVE COMPARATOR

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

Drug: Tildrakizumab

Part B- 1: Placebo and active comparator controlled study

EXPERIMENTAL

Drug: Placebo; Drug: Tildrakizumab; Drug: Etanercept

Part B-2: Randomized withdrawal and retreatment after relapse

EXPERIMENTAL

Drug: Tildrakizumab; Drug: Placebo

Part B 3: Efficacy and Safety Follow-up

NO INTERVENTION

Part C: LTE

EXPERIMENTAL

Drug: Tildrakizumab

Interventions

Tildrakizumab DRUG

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

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

Placebo DRUG

(Weeks 0 to 16)

Part B- 1: Placebo and active comparator controlled study

Etanercept DRUG

(Weeks 0 to 16)

Part B- 1: Placebo and active comparator controlled study

Eligibility Criteria

• Age: 6 Years - 215 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (27)

Site 1

Fountain Valley, California, 92708, United States

Location

Site 2

Thousand Oaks, California, 91320, United States

Location

Site 20

Miami, Florida, 33126, United States

Location

Site 7

Miami, Florida, 33173, United States

Location

Site 14

Spokane, Washington, 99202, United States

Location

Site 63

Budapest, H-1033, Hungary

Location

Site 62

Budapest, H-1036, Hungary

Location

Site 61

Debrecen, H-4032, Hungary

Location

Site 64

Kaposvár, H-7400, Hungary

Location

Site 79

Ahmedabad, 380009, India

Location

Site 71

Lucknow, 226005, India

Location

Site 74

Surat, 395002, India

Location

Site 57

Bialystok, 15-453, Poland

Location

Site 51

Katowice, 40-611, Poland

Location

Site 54

Lodz, 90-265, Poland

Location

Site 56

Lodz, 90-436, Poland

Location

Site 58

Lublin, 20-573, Poland

Location

Site 50

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Site 59

Sosnowiec, 41-200, Poland

Location

Site 52

Szczecin, 70-332, Poland

Location

Site 53

Warsaw, 02-507, Poland

Location

Site 39

Wroclaw, 51-503, Poland

Location

Site 92

Bardejov, 8501, Slovakia

Location

Site 91

Svidník, 8901, Slovakia

Location

Site 90

Trnava, 91775, Slovakia

Location

Site 41

Barcelona, 08041, Spain

Location

Site 47

Las Palmas de Gran Canaria, 35019, Spain

Location

MeSH Terms

Interventions

tildrakizumab; Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study will follow three distinct components: Open-label PK, blinded Randomized Trial Component (RCT) with open-label comparator followed by the open-label extension.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 25, 2019
• Study Start: January 15, 2020
• Primary Completion: April 7, 2025
• Study Completion (Estimated): August 5, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

SL (3); US (5); PL (10); ES (2); HU (4); IN (3)