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Treatment of chronic plaque psoriasis in children with Tildrakizumab

A 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

Phase2; Phase3 Interventional Sun Pharmaceutical Industries Limited · NCT03997786

This study is testing if a new medication called Tildrakizumab can help children aged 6 to 17 with moderate-to-severe psoriasis feel better and improve their quality of life.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment130 (estimated)
Ages6 Years to 215 Months
SexAll
SponsorSun Pharmaceutical Industries Limited Industry-sponsored
Locations50 sites (Birmingham, Alabama and 49 other locations)
Trial IDNCT03997786 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Tildrakizumab in pediatric patients aged 6 to 17 years with moderate-to-severe chronic plaque psoriasis. It consists of three parts: an open-label pharmacokinetic (PK) study in adolescents, followed by a randomized trial in younger children, and a long-term extension phase. The study aims to assess the drug's performance in managing psoriasis symptoms and improving the quality of life for affected children.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 years with moderate-to-severe chronic plaque psoriasis inadequately controlled by topical treatments.

Not a fit: Patients with predominantly non-plaque forms of psoriasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of chronic plaque psoriasis in pediatric patients.

How similar studies have performed: Previous studies have shown promising results with similar biologic treatments for psoriasis, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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, meaning psoriasis inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy
* 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 surface (HBS) antigen, or hepatitis C virus (HCV) test result

Where this trial is running

Birmingham, Alabama and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderate-to-severe Chronic Plaque Psoriasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.