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Study on Guselkumab and Etanercept for Treating Chronic Plaque Psoriasis in Children Aged 6 to 17 Years

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What is this study about?

This clinical trial is focused on studying the treatment of Chronic Plaque Psoriasis in children and teenagers aged 6 to 18 years. The study will evaluate the effectiveness and safety of a medication called Guselkumab, which is a type of protein known as a monoclonal antibody. This medication is given as an injection under the skin using a pre-filled syringe. The trial will also compare Guselkumab with another medication called Etanercept, which is also used to treat psoriasis, and with a placebo.

The purpose of the study is to assess how well Guselkumab works in reducing the symptoms of Chronic Plaque Psoriasis in young patients. Participants in the study will receive either Guselkumab, Etanercept, or a placebo. The study will last for a period of up to 52 weeks, during which participants will receive regular injections and attend follow-up visits to monitor their progress and any side effects. The study aims to determine if Guselkumab can help improve the condition of the skin and overall health of the participants.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and well-being. The trial will provide valuable information on the use of Guselkumab in treating Chronic Plaque Psoriasis in a younger population, potentially offering a new treatment option for those affected by this condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study criteria.

You will be asked to provide evidence of immunity to certain diseases, such as varicella and measles, mumps, and rubella (MMR). This can be through vaccination records or a blood test showing protective antibodies.

2 baseline assessment

A baseline assessment will be conducted to evaluate the severity of your chronic plaque psoriasis. This includes measuring the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA).

The assessment will help determine the extent of your skin condition and ensure it meets the study’s requirements.

3 treatment phase

You will be randomly assigned to receive either guselkumab or etanercept, or a placebo. The medication will be administered through a subcutaneous injection, which means it is injected under the skin.

If you receive guselkumab, it will be provided as a 100 mg/mL solution in a pre-filled syringe. If you receive etanercept, it will be provided as a 25 mg or 50 mg solution for injection.

The frequency and duration of the medication administration will be explained to you by the healthcare team.

4 follow-up visits

You will have regular follow-up visits to monitor your response to the treatment and any side effects. These visits will include physical examinations and assessments of your psoriasis.

The primary goal is to evaluate the proportion of participants achieving a PASI 75 response at week 16, which means a 75% improvement in the severity and extent of psoriasis.

5 end of study

At the end of the study, a final assessment will be conducted to evaluate the overall effectiveness and safety of the treatment.

You will be informed about the results of your participation and any further steps if necessary.

Who Can Join the Study?

  • Must have a diagnosis of chronic plaque psoriasis for at least 6 months. This means having a skin condition with red, scaly patches for a long time.
  • Must have a certain level of psoriasis severity, which includes:
    • Investigator Global Assessment (IGA) score of 3 or higher. This is a way doctors rate the severity of psoriasis.
    • Psoriasis Area and Severity Index (PASI) score of 12 or higher. This is another way to measure how severe the psoriasis is.
    • Psoriasis covering 10% or more of the body.
    • At least one of the following: very thick skin patches, psoriasis on the face, genitals, hands, or feet, PASI score of 20 or higher, psoriasis covering more than 20% of the body, or IGA score of 4.
  • Must be a candidate for phototherapy or systemic treatment for psoriasis. Phototherapy is a treatment using light, and systemic treatment involves medication that affects the whole body.
  • Psoriasis must not be well controlled with phototherapy or creams/ointments after trying them for a sufficient time.
  • Must be considered suitable for etanercept therapy by the doctor. Etanercept is a medication used to treat psoriasis.
  • Must be otherwise healthy based on a physical exam, medical history, and vital signs. Any health issues should be related to psoriasis and noted by the doctor.
  • Must have proof of immunity to varicella (chickenpox) and measles, mumps, and rubella (MMR)</b). This can be shown by:
    • Having received the full set of vaccines for these diseases.
    • Having had these diseases in the past, confirmed by a doctor.
    • Having positive antibody tests showing protection against these diseases.

Who Cannot Join the Study?

  • 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 severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received any other treatment for psoriasis within a certain period before the study starts.
  • Patients who have any significant medical conditions that could affect their participation in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been vaccinated with a live vaccine within a certain period before the study.
  • Patients who have any known immune system disorders.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Dermed Centrum Medyczne Sp. z o.o. Lodz Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Azienda Ospedaliera di Padova Padua Italy
University Of Debrecen Debrecen Hungary
Universita’ Politecnica Delle Marche Ancona Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Cmdialdja Unsvbygslbtyyg Sdhamcqfe Woluwe-Saint-Lambert Belgium
Shdyeiq Dystflzrk Isu Plgnx Dc Mfzu Jjgh Bldkdocfmrjq Sgpndbzpomo Pwkeaqlwl Zbximr Oibqli Zzqofnhniq Warsaw Poland
Awlmsgx Upihf Sftyswnhk Lqaxxz Dq Biqepem Bologna Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
26.06.2018
Germany Germany
Not recruiting
26.06.2018
Hungary Hungary
Not recruiting
26.06.2018
Italy Italy
Not recruiting
26.06.2018
Poland Poland
Not recruiting
26.06.2018

Trial locations

Investigated drugs:

Guselkumab is a medication used in this clinical trial to treat chronic plaque psoriasis in children and teenagers. It is given as an injection under the skin. Guselkumab works by targeting a specific protein in the body that causes inflammation and skin symptoms in psoriasis. By blocking this protein, the medication helps reduce the redness, thickness, and scaling of the skin patches associated with psoriasis. This trial aims to see how well guselkumab works and how safe it is for young patients with this skin condition.

Investigated diseases:

Chronic Plaque Psoriasis – Chronic Plaque Psoriasis is a long-lasting autoimmune skin condition characterized by the rapid growth of skin cells, leading to thick, red, scaly patches on the skin. These patches, known as plaques, often appear on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The condition is caused by an overactive immune system that mistakenly attacks healthy skin cells, causing inflammation and accelerated skin cell production. The plaques can be itchy, painful, and may crack and bleed. The severity of the disease can vary, with some individuals experiencing only minor irritation, while others may have widespread, severe plaques. The condition tends to go through cycles, with periods of flare-ups followed by times of remission.

Trial ID:
2023-503378-19-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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