Study of Risankizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

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What is this study about?

This clinical trial is focused on studying a skin condition called plaque psoriasis, which is a chronic disease that causes red, scaly patches on the skin. The study is specifically for children and teenagers aged 6 to less than 18 years who have moderate to severe forms of this condition. The treatment being tested is a medication called Risankizumab, which is given as an injection under the skin. The purpose of the study is to evaluate how this medication works in young patients, including its safety and effectiveness, and to see if it provides similar benefits as it does in adults.

Participants in the study will receive either Risankizumab or another treatment called Stelara (Ustekinumab), which is also an injection. Some participants may receive a placebo. The study will last for a period of up to 40 weeks, during which the participants will have regular check-ups to monitor their health and the effects of the treatment. The study aims to see if the symptoms of plaque psoriasis improve, such as a reduction in the size and severity of the skin patches.

Throughout the study, the participants’ quality of life will also be assessed, including how the condition affects their daily activities and well-being. The study will help determine if Risankizumab is a safe and effective treatment option for young people with moderate to severe plaque psoriasis, potentially offering a new way to manage this challenging condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the study will be confirmed based on your medical history and current health status.

You will undergo a physical examination and provide information about your plaque psoriasis condition, including its duration and severity.

2 baseline assessment

A baseline assessment will be conducted to evaluate the current state of your plaque psoriasis. This includes measuring the affected body surface area and scoring the severity of your condition.

These assessments will help determine the starting point for your treatment and track changes over time.

3 treatment phase

You will begin the treatment phase, where you will receive the medication risankizumab as a subcutaneous injection. This means the medication will be injected under your skin.

The dosage and frequency of the injections will be determined by the study protocol and your healthcare provider. The initial treatment phase lasts for 16 weeks.

4 follow-up visits

Throughout the treatment phase, you will have regular follow-up visits. These visits are important to monitor your response to the medication and any side effects you may experience.

During these visits, your healthcare provider will assess the improvement in your plaque psoriasis and adjust the treatment plan if necessary.

5 assessment of treatment response

At the end of the initial 16-week treatment phase, your response to the medication will be evaluated. This includes checking for improvements in your psoriasis symptoms and overall skin condition.

The primary goal is to achieve a significant reduction in the severity of your plaque psoriasis.

6 re-treatment phase

If necessary, you may enter a re-treatment phase. This phase involves additional treatment with risankizumab to further improve your condition.

The re-treatment phase also lasts for 16 weeks, with regular assessments to monitor progress and adjust treatment as needed.

7 final evaluation

At the conclusion of the study, a final evaluation will be conducted to assess the overall effectiveness and safety of the treatment.

This evaluation will help determine the long-term benefits and any potential risks associated with the medication.

Who Can Join the Study?

Must have a diagnosis of chronic plaque psoriasis for at least 6 months before the start of the study. (Chronic plaque psoriasis is a long-lasting skin condition that causes red, scaly patches on the skin.)
Must have stable severe or moderate to severe plaque psoriasis. (This means the condition is not changing much and is either severe or moderate to severe, based on how much of the body is affected and specific scoring systems used by doctors.)
Must be a candidate for systemic therapy. (Systemic therapy is a treatment that affects the entire body, not just the skin. The doctor will decide if this type of treatment is suitable based on the condition’s activity at the start of the study.)
Must be between 6 to less than 18 years old.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to similar medications.
Patients who are pregnant or breastfeeding.
Patients who have received certain vaccines recently.
Patients who have a history of drug or alcohol abuse.
Patients who have certain blood disorders.
Patients who have had a recent surgery.
Patients who have a history of cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Dermed Centrum Medyczne Sp. z o.o.	Lodz	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Complexo Hospitalario Universitario De Pontevedra	Pontevedra	Spain
Dorota Bystrzanowska High Med Przychodnia Specjalistyczna	Warsaw	Poland
Ugrdazunmgpmwfrvdkcnq Mfbmkepf Axx	Munster	Germany
Clfdupl Bdegt Kpzmvcocoja Prgbhxqc Sju z osbo	Gdansk	Poland
Tkzcrakwevk uxg Sfykbswpiod Buhzggam Gzgj	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.10.2021
Poland	Not recruiting	01.10.2021
Spain	Not recruiting	01.10.2021

Trial locations

Investigated drugs:

Risankizumab is a medication used in this clinical trial to treat children and teenagers with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin. Risankizumab works by targeting a specific part of the immune system that is involved in the development of psoriasis. By doing this, it helps to reduce the inflammation and skin symptoms associated with the condition. The trial aims to see if risankizumab is safe and effective for younger patients, similar to how it works in adults. Participants in the trial receive this medication to help manage their psoriasis symptoms and improve their quality of life.

Investigated diseases:

Psoriasis

Plaque Psoriasis – Plaque psoriasis is a chronic autoimmune condition characterized by the rapid growth of skin cells, leading to the formation of 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, accelerating their production. As the skin cells build up, they form scales and red patches that can be itchy and sometimes painful. The progression of plaque psoriasis can vary, with periods of flare-ups followed by times of remission. Environmental factors, stress, and certain medications can trigger or worsen the symptoms.

Trial ID:

2023-504156-10-00

Protocol code:

M19-977

NCT ID:

NCT04435600

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Risankizumab and Ustekinumab for Children and Teens with Moderate to Severe Plaque Psoriasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?