Overall trial status: Ongoing, recruitment ended
Trial title: A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENT FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Medical conditions: Moderate to Severe Plaque Psoriasis
Status in each country: Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, France:Ended, Hungary:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended
Trial phase: Therapeutic confirmatory (Phase III)
Therapeutic Areas: Diseases [C] - Immune System Diseases [C20]
Primary end point: Psoriasis Area Severity Index 90 (PASI90) response at Week 16, Investigator´s Global Assessment (IGA) 0/1 response at Week 16
Secondary end point: PASI75 response at Week 4, PASI100 response at Week 16, PASI90 response at Week 48, IGA 0/1 response at Week 48, PASI100 response at Week 48, IGA 0 response at Week 16, IGA 0 response at Week 48, Treatment-emergent adverse events (TEAE)s, Serious TEAEs, TEAEs leading to discontinuation of investigational medicinal product (IMP), TEAEs leading to withdrawal from the study, Selected safety topics of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease (IBD), and injection site reactions) with onset occurring from day of first dose through 20 weeks after final dose of IMP adjusted by duration of study participant exposure to IMP, Change from Baseline in vital signs, Change from Baseline in physical examination findings, Change from Baseline in height (growth assessment), Change from Baseline in weight (growth assessment), Change from Baseline in laboratory analyses (chemistry and hematology), Change from Baseline in Children’s Dermatology Life Quality Index (CDLQI) total score at Week 16, Change from Baseline in CDLQI total score at Week 48, Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile psoriatic arthritis (PsA) prior to Baseline, Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16, Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period, Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
Age of participants: 0-17 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 122
Sponsor: UCB Biopharma
Sponsor type: Pharmaceutical company
Trial product: Placebo matching test and comparator. 0.9% sodium chloride solution for injection (unauthorized), ustekinumab, Placebo matching test and comparator. 0.9% sodium chloride solution for injection (authorized - MA number: 6697366.00.00), bimekizumab
Results posted: No
Overall decision date: 15/07/2024
Countries decision date: CZ: 17/07/2024, FR: 15/07/2024, HU: 17/07/2024, ES: 16/07/2024, IT: 13/09/2024, BE: 22/07/2024, PL: 22/07/2024, DE: 17/07/2024
Last updated date: 27/02/2026
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