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

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

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
Uvavdytfkkcrlhremfgff Mbcpgjxq Afn	Munster	Germany
Cbwfajc Bywzj Kmsfqrzpozt Pjsgtwks Smr z ovsc	Gdansk	Poland
Twsxrrbftrz ung Szlbqdhrtse Byliajvp Gfon	Bad Bentheim	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2022
Poland	Recruiting	01.10.2022
Spain	Recruiting	01.10.2022

Trial locations

Investigated drugs:

Risankizumab

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.

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 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.

Trial ID:

2022-500408-22-00

Protocol code:

M19-973

NCT ID:

NCT04862286

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?