Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977
This study is for young people between 6 and 17 years old who have moderate to severe plaque psoriasis. It focuses on a medicine called risankizumab, which is given by injection under the skin. We want to understand if it's safe for children and how well it helps control their psoriasis, especially for those who have already participated in an earlier study (M19-977). Psoriasis causes red, patchy, and scaly skin. While risankizumab is approved for adults, this research helps us learn more about its use in younger people. Participants will receive injections every 12 weeks for about 4 years, with follow-up after the last dose. There will be regular hospital or clinic visits to monitor health and the medicine's effects.
At a glance
What is this study about?
This research study is about a medicine called risankizumab, which is being investigated for children and teenagers aged 6 to 17 who have moderate to severe plaque psoriasis. You might know psoriasis as a skin condition where your skin cells grow too quickly, leading to thick, red, and scaly patches.
Risankizumab is already a proven treatment for adults with moderate to severe plaque psoriasis. This study aims to gather more information about its safety and how well it works specifically in younger people. We're also interested in understanding any side effects that might occur.
This study is for young people who previously took part in another study (M19-977) involving risankizumab. By continuing to follow these participants, we can get a clearer picture of the long-term effects of this medicine in a way that is important for approving treatments for children and teenagers.
Key takeaways
- This study is for young people (6-17) with moderate to severe psoriasis.
- It's testing a medicine called risankizumab already used by adults.
- Participation means regular injections and hospital visits over 4-5 years.
- It aims to understand the medicine's safety and effectiveness in children.
- Only participants from a previous study (M19-977) can join this one.
Who may be eligible?
To be able to join this study, a young person must have successfully finished taking part in an earlier study called M19-977. This means they completed all the necessary steps and met the requirements of that previous study.
However, a young person cannot join this study if they had to stop their participation in the M19-977 study for specific reasons. These reasons would have been clearly explained when they were in the first study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 6 and 17 years old?
- Do you have moderate to severe plaque psoriasis?
- Have you already completed all parts of the M19-977 study?
- Were you able to continue in the M19-977 study without needing to stop early due to specific reasons?
What does participation involve?
If you join this study, you'll receive risankizumab injections under your skin every 12 weeks. This treatment will continue for about 204 weeks, which is roughly four years. After your last injection, doctors will continue to check on your health and safety for another 20 weeks.
Throughout the study, you'll need to attend regular appointments at a hospital or clinic. These visits are important for doctors to check how you're doing. They'll carry out medical check-ups, take blood samples, ask you to fill in questionnaires, and look out for any side effects. This helps them understand how the medicine is affecting your psoriasis and your overall health.
Potential risks and benefits
Locations (41)
- UAB Department of Dermatology /ID# 252305Verified postcodeBirmingham, United States
- First OC Dermatology /ID# 226942Verified postcodeFountain Valley, United States
- Integrative Skin Science and Research /ID# 226108Verified postcodeSacramento, United States
- University of California San Diego - Rady Children's Hospital San Diego /ID# 252348Verified postcodeSan Diego, United States
- Solutions Through Adv Rch /ID# 226104Verified postcodeJacksonville, United States
- Olympian Clinical Research- St. Petersburg /ID# 226106Verified postcodeSt. Petersburg, United States
- Advanced Clinical Research Institute /ID# 248827Verified postcodeTampa, United States
- University Dermatology and Vein Clinic, LLC /ID# 226100Verified postcodeDarien, United States
- Arlington Dermatology /ID# 226097Verified postcodeRolling Meadows, United States
- Skin Cancer and Dermatology Institute - Reno /ID# 248828Verified postcodeReno, United States
- Univ Hosp Cleveland /ID# 248825Verified postcodeCleveland, United States
- Apex Clinical Research Center /ID# 248830Verified postcodeMayfield Heights, United States
Common questions
What is risankizumab?
Risankizumab is a medicine that helps reduce the inflammation that causes psoriasis. It's already used for adults and is being studied for children.
How often will I receive the medicine?
You will receive an injection under your skin every 12 weeks.
How long will the study last?
The treatment period is about 4 years (204 weeks), followed by a 20-week safety check.
Will I have to go to the hospital a lot?
Yes, you will have regular visits to a hospital or clinic for check-ups and to get your medicine.
Is this study only for children who were in another study?
Yes, this study is only for children and teenagers who have already completed the M19-977 study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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