M19-973 - Paediatric Psoriasis Follow on Study
Research type
Research Study
Full title
OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1).
IRAS ID
1005693
Contact name
Aleksandra Jankielewicz
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2021-000090-82
Clinicaltrials.gov Identifier
Research summary
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in paediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.
Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the paediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.
Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0133
Date of REC Opinion
15 Jul 2022
REC opinion
Further Information Favourable Opinion