A Multicenter, Randomized, Parallel-Group, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to \<18 years of age with moderate to severe plaque psoriasis (PSO).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Study participant must be 6 to \<18 years of age, inclusive, at the time of signing the informed consent/assent according to local regulation
• Study participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit
• Study participant meets the following at both the Screening and Baseline Visits:
‣ Body surface area (BSA) affected by PSO ≥10%
⁃ . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
⁃ . Psoriasis Area and Severity Index (PASI) score ≥12 OR
∙ PASI score ≥10 plus at least 1 of the following:
∙ i) Clinically relevant facial involvement ii) Clinically relevant genital involvement iii) Clinically relevant hand and foot involvement
• Study participant is a candidate for systemic PSO therapy and/or photo/chemotherapy and for treatment with ustekinumab per labeling
• Study participant has body weight ≥15 kg and body mass index for age percentile of ≥5 at Screening
Locations
United States
California
Ps0021 50162
ACTIVE_NOT_RECRUITING
Fountain Valley
Ps0021 50161
ACTIVE_NOT_RECRUITING
Los Angeles
Ps0021 50196
COMPLETED
Northridge
Florida
Ps0021 50581
RECRUITING
Miami
Indiana
Ps0021 50344
ACTIVE_NOT_RECRUITING
Indianapolis
New York
Ps0021 50599
RECRUITING
Kew Gardens
South Carolina
Ps0021 50084
ACTIVE_NOT_RECRUITING
Charleston
Texas
Ps0021 50201
ACTIVE_NOT_RECRUITING
Arlington
Ps0021 50355
ACTIVE_NOT_RECRUITING
Dallas
Other Locations
Belgium
Ps0021 40121
ACTIVE_NOT_RECRUITING
Brussels
Ps0021 40420
RECRUITING
Liège
Canada
Ps0021 50618
ACTIVE_NOT_RECRUITING
Mississauga
Ps0021 50357
ACTIVE_NOT_RECRUITING
St. John's
Ps0021 50617
RECRUITING
St. John's
France
Ps0021 40742
RECRUITING
Argenteuil
Ps0021 40754
RECRUITING
Nantes
Germany
Ps0021 40740
ACTIVE_NOT_RECRUITING
Bad Bentheim
Ps0021 40515
COMPLETED
Berlin
Ps0021 40138
RECRUITING
Bonn
Ps0021 40356
ACTIVE_NOT_RECRUITING
Dresden
Ps0021 40023
ACTIVE_NOT_RECRUITING
Erlangen
Ps0021 40645
ACTIVE_NOT_RECRUITING
Frankfurt Am Main
Ps0021 40758
ACTIVE_NOT_RECRUITING
Hamburg
Ps0021 40249
ACTIVE_NOT_RECRUITING
Kiel
Ps0021 40747
COMPLETED
Mainz
Ps0021 40177
ACTIVE_NOT_RECRUITING
Münster
Hungary
Ps0021 40746
ACTIVE_NOT_RECRUITING
Debrecen
Ps0021 40744
ACTIVE_NOT_RECRUITING
Kaposvár
Ps0021 40745
ACTIVE_NOT_RECRUITING
Szeged
Italy
Ps0021 40440
ACTIVE_NOT_RECRUITING
Ancona, Località Torrette
Ps0021 40749
ACTIVE_NOT_RECRUITING
Catania
Ps0021 40085
ACTIVE_NOT_RECRUITING
Pisa
Ps0021 40567
ACTIVE_NOT_RECRUITING
Roma
Japan
Ps0021 20071
RECRUITING
Nagasaki
Ps0021 20033
RECRUITING
Nagoya
Ps0021 20337
RECRUITING
Shimotsuga-gun
Poland
Ps0021 40741
ACTIVE_NOT_RECRUITING
Bialystok
Ps0021 40625
ACTIVE_NOT_RECRUITING
Lodz
Ps0021 40832
ACTIVE_NOT_RECRUITING
Lodz
Ps0021 40091
ACTIVE_NOT_RECRUITING
Nowa Sól
Ps0021 40737
ACTIVE_NOT_RECRUITING
Rzeszów
Ps0021 40743
ACTIVE_NOT_RECRUITING
Szczecin
Ps0021 40334
ACTIVE_NOT_RECRUITING
Wroclaw
Ps0021 40738
ACTIVE_NOT_RECRUITING
Wroclaw
Spain
Ps0021 40750
ACTIVE_NOT_RECRUITING
Alicante
Ps0021 40159
RECRUITING
Barcelona
Ps0021 40751
ACTIVE_NOT_RECRUITING
Esplugues De Llobregat
Ps0021 40752
ACTIVE_NOT_RECRUITING
Granada
Ps0021 40753
RECRUITING
Santiago De Compostela
Contact Information
Primary
UCB Cares
ucbcares@ucb.com
1-844-599-2273 (USA)
Backup
UCB Cares
UCBCares@ucb.com
001 844 599 2273
Time Frame
Start Date:2024-06-25
Estimated Completion Date:2030-11-08
Participants
Target number of participants:168
Treatments
Experimental: bimekizumab
Study participants randomized to this arm receive bimekizumab dosage regimen 1 at pre-specified timepoints during the Initial Treatment Period (16 weeks). They continue to receive bimekizumab dosage regimen 2 in the Maintenance Period (32 weeks). Under certain conditions study participants may be offered to continue on bimekizumab dosage regimen 2 in the Open-label Extension (OLE) Period (104 weeks).
Active_comparator: ustekinumab
Study participants randomized to this arm receive ustekinumab at pre-specified timepoints during the Initial Treatment Period (16 weeks) and during the Maintenance Period. Under certain conditions participants may switch to bimekizumab dosage regimen 1 (16 weeks) and continue with bimekizumab dosage regimen 2 in the last 16 weeks of the Maintenance Period. Under certain conditions study participants may be offered to participate in the OLE Period also receiving bimekizumab dosage regimen 2.