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 (48) 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
RECRUITING
Fountain Valley
Ps0021 50161
RECRUITING
Los Angeles
Ps0021 50196
RECRUITING
Northridge
Florida
Ps0021 50581
RECRUITING
Miami
Indiana
Ps0021 50344
RECRUITING
Indianapolis
New York
Ps0021 50599
RECRUITING
Kew Gardens
South Carolina
Ps0021 50084
RECRUITING
Charleston
Texas
Ps0021 50201
RECRUITING
Arlington
Ps0021 50355
RECRUITING
Dallas
Other Locations
Belgium
Ps0021 40121
RECRUITING
Brussels
Ps0021 40420
RECRUITING
Liège
Canada
Ps0021 50618
RECRUITING
Mississauga
Ps0021 50357
RECRUITING
St. John's
Ps0021 50617
RECRUITING
St. John's
France
Ps0021 40742
RECRUITING
Argenteuil
Ps0021 40754
RECRUITING
Nantes
Germany
Ps0021 40740
RECRUITING
Bad Bentheim
Ps0021 40515
RECRUITING
Berlin
Ps0021 40138
RECRUITING
Bonn
Ps0021 40356
RECRUITING
Dresden
Ps0021 40023
RECRUITING
Erlangen
Ps0021 40645
RECRUITING
Frankfurt Am Main
Ps0021 40758
RECRUITING
Hamburg
Ps0021 40249
RECRUITING
Kiel
Ps0021 40747
RECRUITING
Mainz
Ps0021 40177
RECRUITING
Münster
Hungary
Ps0021 40746
RECRUITING
Debrecen
Ps0021 40744
RECRUITING
Kaposvár
Ps0021 40745
RECRUITING
Szeged
Italy
Ps0021 40440
RECRUITING
Ancona, Località Torrette
Ps0021 40749
RECRUITING
Catania
Ps0021 40085
RECRUITING
Pisa
Ps0021 40567
RECRUITING
Roma
Japan
Ps0021 20033
RECRUITING
Nagoya
Ps0021 20337
RECRUITING
Shimotsuga-gun
Poland
Ps0021 40741
RECRUITING
Bialystok
Ps0021 40625
RECRUITING
Lodz
Ps0021 40832
RECRUITING
Lodz
Ps0021 40091
RECRUITING
Nowa Sól
Ps0021 40737
RECRUITING
Rzeszów
Ps0021 40743
RECRUITING
Szczecin
Ps0021 40334
RECRUITING
Wroclaw
Ps0021 40738
RECRUITING
Wroclaw
Spain
Ps0021 40750
RECRUITING
Alicante
Ps0021 40159
RECRUITING
Barcelona
Ps0021 40751
RECRUITING
Esplugues De Llobregat
Ps0021 40752
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.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov

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