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Study on Tildrakizumab and Etanercept for Children Aged 6 to 17 with Moderate to Severe Plaque Psoriasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called tildrakizumab in children aged 6 to under 18 years who have moderate to severe chronic plaque psoriasis. Chronic plaque psoriasis is a skin condition that causes red, scaly patches on the skin. The study aims to understand how well tildrakizumab works and how safe it is for children with this condition. Tildrakizumab is given as a solution for injection under the skin. Another medication, etanercept, and a placebo are also part of the study for comparison purposes.

The study is divided into two parts. In the first part, researchers will determine the best dose of tildrakizumab for children by observing its effects over a 16-week period. In the second part, the study will compare the effectiveness of tildrakizumab to a placebo by measuring improvements in the skin condition of the participants. The goal is to see if there is at least a 75% improvement in the Psoriasis Area & Severity Index (PASI 75 response) and a significant reduction in the Physician’s Global Assessment (PGA) score by the end of the 16 weeks.

Participants will receive injections and be monitored throughout the study to assess the medication's impact on their psoriasis. The study will help determine if tildrakizumab is a suitable treatment option for children with moderate to severe chronic plaque psoriasis. The trial is expected to continue until 2025, providing valuable information on the safety and effectiveness of this treatment in the pediatric population.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant is required to meet specific criteria, including age between 6 and 17 years, a negative tuberculosis test, and appropriate vaccination status.
A physical examination and laboratory tests are conducted to ensure health parameters are within acceptable limits.
Step 2
Part A: Dose finding
This phase lasts for 16 weeks and involves determining the appropriate dose of tildrakizumab for children.
The medication is administered as a solution for injection under the skin (subcutaneous use).
Step 3
Part B: Randomized trial
Participants are randomly assigned to receive either tildrakizumab, a placebo, or an active comparator.
The goal is to evaluate the effectiveness of tildrakizumab in improving skin condition, measured by a 75% improvement in the Psoriasis Area & Severity Index (PASI 75) and a reduction in the Physician's Global Assessment (PGA) score.
Step 4
Medication administration
Tildrakizumab is administered as a subcutaneous injection. The dosage is determined based on weight and is comparable to adult dosing regimens.
The treatment period in Part B also lasts for 16 weeks.
Step 5
Assessment and monitoring
Throughout the trial, regular assessments are conducted to monitor the participant's response to the medication and any side effects.
These assessments include physical examinations, laboratory tests, and evaluations of skin condition.
Step 6
Completion of the trial
At the end of the trial, the participant's overall response to the treatment is evaluated.
The study aims to conclude by April 2025, with all data collected and analyzed to determine the efficacy and safety of tildrakizumab in treating moderate to severe chronic plaque psoriasis in children.

Who can join the trial?

13 criteria

The participant must be between 6 and 17 years old, can be of any gender, race, or ethnicity, and must weigh more than 15 kg (about 33 pounds) at the time of screening.
The participant must have a negative test for tuberculosis (TB) within 4 weeks before starting the study medication. If the test is positive or unclear, the participant can still join if they have no history or symptoms of active TB, a clear chest X-ray, and have followed treatment guidelines for latent TB if needed.
The participant should have up-to-date vaccinations appropriate for their age. If necessary, antibody levels may be checked during screening.
The participant must be unlikely to become pregnant. This can be shown by being male, being a female who agrees to avoid heterosexual activity, or using a reliable method of birth control. Females who are surgically sterilized or have not started menstruating are also eligible.
For females who can become pregnant, a negative pregnancy test is required at screening and within 24 hours before the first dose of study medication, as well as at all subsequent visits.
The participant must have normal or acceptable results from blood tests, urine tests, and a physical examination before starting the study medication. If there are any concerns about test results, the study doctor may discuss them with a medical expert.
The participant must be willing and able to follow the study's rules and schedule.
The participant must have completed at least 64 weeks of the previous part of the study.
The participant must have a Physician's Global Assessment (PGA) score of 2 or less at the start of the next part of the study.
The participant must be willing to participate in whole-body photography if required, but this is optional and not mandatory for the study.
The participant must have had plaque psoriasis for at least 6 months, confirmed by a doctor.
The participant must have moderate to severe psoriasis, which means at least 10% of their body is affected, a PGA score of 3 or more, and a Psoriasis Area and Severity Index (PASI) score of 12 or more.
The participant must be considered suitable for systemic therapy (treatment affecting the whole body) or phototherapy (light treatment).

Who cannot join the trial?

10 criteria

Patients who have any other skin conditions that might interfere with the study results.
Patients who have had any recent infections that required treatment with antibiotics or other medications.
Patients who have a history of allergic reactions to similar medications.
Patients who are currently taking other medications that might interfere with the study drug.
Patients who have any serious health conditions that could affect their participation in the study.
Patients who have received any other treatments for psoriasis within a certain period before the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures or follow-up visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o.
Sosnowiec, Poland
Verified
Dermedic Jacek Zdybski
Ostrowiec Swietokrzyski, Poland
Verified
El Hospital Universitario De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria, Spain

Trial locations

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Investigated drugs

Tildrakizumab is a medication being studied for its effectiveness and safety in treating children and teenagers with moderate to severe chronic plaque psoriasis. This medication is designed to help reduce the symptoms of psoriasis, such as red, scaly patches on the skin, by targeting specific proteins in the immune system that contribute to inflammation. The trial aims to find the right dose for young patients and to see how well it works in improving their skin condition over a 16-week period.

What is already known about the treatment

Tildrakizumab – Tildrakizumab is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating moderate to severe chronic plaque psoriasis in pediatric patients aged 6 to under 18 years. It is a monoclonal antibody that targets the interleukin-23 (IL-23) protein, which plays a role in inflammatory processes. By inhibiting IL-23, tildrakizumab helps reduce inflammation and the symptoms of psoriasis. It is classified as an immunosuppressive agent and is being evaluated for its safety and efficacy in achieving significant improvement in psoriasis symptoms compared to placebo.

Investigated diseases

Chronic Plaque Psoriasis – Chronic plaque psoriasis is a common skin condition characterized by the development of thick, red patches covered with silvery scales. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The disease is caused by an overactive immune system that speeds up the growth cycle of skin cells. It can vary in severity, with some individuals experiencing only minor patches and others having widespread, painful plaques. The condition tends to be persistent, with periods of improvement and worsening. It is not contagious and can affect individuals of any age, though it often begins in childhood or young adulthood.