MedTrace Logo

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

NCT03997786 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-04-15

No results posted yet for this 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)

Conditions

  • Moderate-to-severe Chronic Plaque Psoriasis

Interventions

DRUG

Tildrakizumab

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

DRUG

Placebo

(Weeks 0 to 16)

DRUG

Tildrakizumab

(Weeks 16 to 52)

DRUG

Tildrakizumab

at every 12 weeks in open label fashion till 5 years (240 weeks).

DRUG

Tildrakizumab

(Weeks 0 to 16)

DRUG

Etanercept

(Weeks 0 to 16)

DRUG

Placebo

(Weeks 16 to 52)

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
215 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2025-04-07
Completion
2031-08-05
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • India
  • Poland
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03997786 on ClinicalTrials.gov