Recruiting

Study on Risankizumab for Children Aged 6-17 With Moderate to Severe Plaque Psoriasis After Completing Previous Study

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Risankizumab in individuals with moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches to appear on the skin. The medication being tested, Risankizumab, is given as a solution for injection under the skin using a pre-filled syringe. The study is an extension of a previous study, and it aims to evaluate the long-term safety, tolerability, and effectiveness of Risankizumab in participants who have already completed the earlier study.

The purpose of this study is to gather more information about how well Risankizumab works and how safe it is for people with moderate to severe plaque psoriasis. Participants in this study will receive the medication through subcutaneous injections, which means the medication is injected just under the skin. The study will monitor participants for any adverse events, which are any unwanted effects that might occur during the treatment. The study will also observe changes in the disease activity to see how well the medication is working over time.

This study is designed to provide valuable insights into the long-term use of Risankizumab for treating moderate to severe plaque psoriasis. By participating in this study, researchers hope to better understand the safety and effectiveness of this treatment option for individuals who have already been part of the previous study. The information gathered will help in determining the potential benefits and risks associated with the continued use of Risankizumab in managing plaque psoriasis.

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
Enrollment
Upon joining the study, confirm that participation in the previous study, M19-977, has been completed and all eligibility criteria for this study are met.
Step 2
Initial assessment
Undergo an initial health assessment to establish a baseline for the study. This may include physical examinations and questionnaires about health and symptoms.
Step 3
Medication administration
Receive the medication risankizumab as a subcutaneous injection. This means the medication is injected under the skin using a pre-filled syringe.
The frequency and dosage of the medication will be determined by the study protocol and communicated during the initial assessment.
Step 4
Regular follow-up visits
Attend regular follow-up visits as scheduled by the study team. These visits are important to monitor health, assess the effects of the medication, and ensure safety.
During these visits, expect to undergo physical examinations and answer questions about any changes in health or symptoms.
Step 5
Reporting adverse events
Report any adverse events or side effects experienced during the study to the study team. This information is crucial for assessing the safety of the medication.
Step 6
Final assessment
At the end of the study, undergo a final health assessment. This will help determine the long-term effects of the medication and overall health status.

Who can join the trial?

5 criteria

Participants must have completed participation in the previous study called Study M19-977.
Participants must meet all the eligibility criteria for the new study, referred to as Study M19-973.
Participants can be of any gender, meaning both male and female participants are eligible.
Participants must be adults, which means they should be 18 years or older.
The study is open to individuals who are considered part of a vulnerable population. This term refers to groups who might need special protection or care, such as those with certain health conditions or disabilities.

Who cannot join the trial?

4 criteria

Patients who have not completed participation in the previous study (Study M19-977) cannot join this study.
Patients with medical conditions other than plaque psoriasis may not be eligible.
Patients who are not within the specified age range for the study may be excluded.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Risankizumab is a medication used in this clinical trial to help people 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 the appearance of the skin patches. This study is focused on understanding how safe and effective risankizumab is when used over a long period. Participants in this trial have already used risankizumab in a previous study, and this trial continues to monitor its effects.

Risankizumab

What is already known about the treatment

Risankizumab – Risankizumab is administered as an injection under the skin, typically in a healthcare setting. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating moderate to severe plaque psoriasis, a skin condition characterized by red, scaly patches. The medication works by targeting a specific protein in the immune system called interleukin-23 (IL-23), which plays a role in inflammation and the overproduction of skin cells. Risankizumab is classified as a monoclonal antibody, a type of drug designed to interact with specific targets in the body to help reduce symptoms and improve skin appearance.

Investigated diseases

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 or plaques on the skin. These plaques often appear on the elbows, knees, scalp, and lower back, but they can occur anywhere on the body. The condition is marked by cycles of flare-ups and remission, where symptoms may improve or worsen over time. The skin lesions can be itchy, painful, and may crack or bleed. The exact cause of plaque psoriasis is not fully understood, but it involves an overactive immune response that accelerates skin cell production. Environmental factors, stress, and infections can trigger or exacerbate the symptoms.