*M19-977 - Paediatric Psoriasis
Research type
Research Study
Full title
A Randomised, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis
IRAS ID
289818
Contact name
Tarakalit Bisola Laguda
Contact email
Eudract number
2019-004141-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 6 days
Research summary
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly plaques on the skin. There is an unmet medical need for effective treatment in paediatric patients and this study is
being done to evaluate Risankizumab in paediatric 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 paediatric 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 and Part 4: Participants aged 6 < 12 will receive Risankizumab based on body weight.
Around 132 participants will be enrolled in approximately 30 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.
Part 2:-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 52 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 clinical assessment, questionnaires, and checking for side effects.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0189
Date of REC Opinion
21 May 2021
REC opinion
Further Information Favourable Opinion