Psoriasis Clinical Trial
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms.
Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts.
Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive;
Period A: Risankizumab or ustekinumab based on body weight followed by;
Period B: Risankizumab or no treatment.
Period C: Re-treatment with risankizumab (if needed).
Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight.
Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 > 18 will receive risankizumab based on body weight).
Around 132 participants will be enrolled in approximately 50 sites worldwide.
Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection.
Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks.
Period A: Risankizumab or ustekinumab for 16 weeks.
Period B: Risankizumab or no treatment for 36 weeks.
Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks.
There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.
Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline Visit.
Stable severe or moderate to severe plaque psoriasis as defined in each study part by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area and Severity Index (PASI) and Static Physician Global Assessment (sPGA).
Candidate for systemic therapy as assessed by the investigator and meet the disease activity criteria at both the Screening and Baseline Visits per the protocol.
- Concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the participant's participation in this study, would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 53 Locations for this study
Birmingham Alabama, 35233, United States
Fountain Valley California, 92708, United States
Sacramento California, 95815, United States
San Diego California, 92123, United States
Fort Lauderdale Florida, 33316, United States
Jacksonville Florida, 32256, United States
Saint Petersburg Florida, 33709, United States
Tampa Florida, 33602, United States
Darien Illinois, 60561, United States
Rolling Meadows Illinois, 60008, United States
Reno Nevada, 89052, United States
Kew Gardens New York, 11415, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Mayfield Heights Ohio, 44124, United States
Tulsa Oklahoma, 74136, United States
Charleston South Carolina, 29425, United States
Arlington Texas, 76011, United States
Morgantown West Virginia, 26506, United States
Kenosha Wisconsin, 53144, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2J 7, Canada
St. John's Newfoundland and Labrador, A1A 4, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Munster Niedersachsen, 48149, Germany
Kiel Schleswig-Holstein, 24105, Germany
Bad Bentheim , 48455, Germany
Bonn , 53127, Germany
Dresden , 01307, Germany
Mainz , 55131, Germany
Nagoya shi Aichi, 467-8, Japan
Hiroshima-shi Hiroshima, 734-8, Japan
Tsu-shi Mie, 514-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Itabashi-ku Tokyo, 173-8, Japan
Shinjuku-ku Tokyo, 160-0, Japan
Lodz Lodzkie, 90-26, Poland
Lodz Lodzkie, 90-43, Poland
Warszawa Mazowieckie, 01-81, Poland
Rzeszow Podkarpackie, 35-05, Poland
Gdansk Pomorskie, 80-54, Poland
Esplugues de Llobregat Barcelona, 08950, Spain
Madrid , 28007, Spain
Madrid , 28031, Spain
Madrid , 28041, Spain
Pontevedra , 36071, Spain
Exeter Devon, EX2 5, United Kingdom
London London, City Of, SE1 9, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Camberley , GU16 , United Kingdom
London , SW10 , United Kingdom
Plymouth , PL6 5, United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.