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Tildrakizumab Efficacy and Safety in Pediatric Moderate to Severe Chronic Plaque Psoriasis

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Study Aim

This study aims to determine the safety and effectiveness of Tildrakizumab in treating moderate to severe chronic plaque psoriasis in children aged 6 to 18, by observing the improvement in their PASI response and PGA scores.

What is being tested

Tildrakizumab

+ Placebo

+ Etanercept

Drug
Who is being recruted

+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorSun Pharmaceutical Industries Limited
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 15, 2020

Actual date on which the first participant was enrolled.

This clinical trial focuses on treating moderate to severe chronic plaque psoriasis in children aged 6 to less than 18 years. The study involves a medication called Tildrakizumab. The trial is divided into three parts: first, a study to understand how the body processes the drug (pharmacokinetics or PK study), then a randomized trial, and finally, a long-term extension. The trial begins with adolescents aged 12 to less than 18 years, and after initial analysis, it includes younger children aged 6 to less than 12 years. The main goals of this study are to determine the right dose for different age groups, understand the safety of the drug, and evaluate its effectiveness in improving psoriasis symptoms. During the trial, participants receive either Tildrakizumab, a placebo, or an active comparator drug. The study measures the number of participants experiencing adverse events to evaluate safety. To assess the effectiveness of the treatment, it measures the proportion of participants with at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) response from the start of the study. It also evaluates the proportion of participants with a Physician's Global Assessment (PGA) score of 'clear' or 'minimal' with at least a 2-grade reduction from the baseline.

Official TitleA Multicenter, Randomized, Placebo and Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety and Pharmacokinetics (PK) of Tildrakizumab in Pediatric Subjects From 6 to <18 Years of Age With Moderate to Severe Chronic Plaque Psoriasis
NCT03997786
Principal SponsorSun Pharmaceutical Industries Limited
Last updated: March 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

135 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Subject must be 6 to < 18 years of age, of either sex, of any race/ ethnicity, must weight greater than or equal to 15Kg
Moderate to severe psoriasis at baseline defined as: at least 10% Body Surface Area (BSA) involvement, PGA score >= 3, and PASI score >= 12
Subject is considered to be eligible according to tuberculosis (TB) screening criteria
Diagnosis of predominantly plaque psoriasis for >= 6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator)
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8 exclusion criteria prevent from participating
Subject who has received any of the prohibited medications, supplements or substances during the study
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 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)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 27 locations

Suspended

Site 1

Fountain Valley, United StatesOpen Site 1 in Google Maps
Suspended

Site 2

Thousand Oaks, United States
Suspended

Site 20

Miami, United States
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Site 7

Miami, United States
Suspended27 Study Centers