A 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
NCT ID: NCT06425549
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
168 participants
INTERVENTIONAL
2024-06-25
2030-11-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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).
bimekizumab
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
placebo
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
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.
bimekizumab
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
ustekinumab
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
placebo
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
Interventions
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bimekizumab
Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.
ustekinumab
Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.
placebo
Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Body surface area (BSA) affected by PSO ≥10%
2. . Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
3. . 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
Exclusion Criteria
* Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
* Study participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
* History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
* Study participant has previously received bimekizumab
* Study participant has previously received ustekinumab
* Study participant has received drugs outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments
* Study participant has the presence of active suicidal ideation, or positive suicide behavior
* Study participant diagnosed with severe depression in the past 6 months (prior to Screening) should be excluded
* Study participant has a history of psychiatric inpatient hospitalization within the past year before enrolling into the study
6 Years
17 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Ps0021 50162
Fountain Valley, California, United States
Ps0021 50161
Los Angeles, California, United States
Ps0021 50196
Northridge, California, United States
Ps0021 50581
Miami, Florida, United States
Ps0021 50344
Indianapolis, Indiana, United States
Ps0021 50599
Kew Gardens, New York, United States
Ps0021 50084
Charleston, South Carolina, United States
Ps0021 50201
Arlington, Texas, United States
Ps0021 50355
Dallas, Texas, United States
Ps0021 40121
Brussels, , Belgium
Ps0021 40420
Liège, , Belgium
Ps0021 50618
Mississauga, , Canada
Ps0021 50357
St. John's, , Canada
Ps0021 50617
St. John's, , Canada
Ps0021 40748
Plzen-bory, , Czechia
Ps0021 40742
Argenteuil, , France
Ps0021 40754
Nantes, , France
Ps0021 40740
Bad Bentheim, , Germany
Ps0021 40515
Berlin, , Germany
Ps0021 40138
Bonn, , Germany
Ps0021 40356
Dresden, , Germany
Ps0021 40023
Erlangen, , Germany
Ps0021 40645
Frankfurt am Main, , Germany
Ps0021 40758
Hamburg, , Germany
Ps0021 40249
Kiel, , Germany
Ps0021 40747
Mainz, , Germany
Ps0021 40177
Münster, , Germany
Ps0021 40746
Debrecen, , Hungary
Ps0021 40744
Kaposvár, , Hungary
Ps0021 40745
Szeged, , Hungary
Ps0021 40440
Ancona, Località Torrette, , Italy
Ps0021 40749
Catania, , Italy
Ps0021 40085
Pisa, , Italy
Ps0021 40567
Roma, , Italy
Ps0021 20071
Nagasaki, , Japan
Ps0021 20033
Nagoya, , Japan
Ps0021 20337
Shimotsuga-gun, , Japan
Ps0021 40741
Bialystok, , Poland
Ps0021 40625
Lodz, , Poland
Ps0021 40832
Lodz, , Poland
Ps0021 40091
Nowa Sól, , Poland
Ps0021 40737
Rzeszów, , Poland
Ps0021 40743
Szczecin, , Poland
Ps0021 40334
Wroclaw, , Poland
Ps0021 40738
Wroclaw, , Poland
Ps0021 40750
Alicante, , Spain
Ps0021 40159
Barcelona, , Spain
Ps0021 40751
Esplugues de Llobregat, , Spain
Ps0021 40752
Granada, , Spain
Ps0021 40753
Santiago de Compostela, , Spain
Countries
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Central Contacts
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Other Identifiers
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U1111-1293-2383
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503859-10-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
PS0021
Identifier Type: -
Identifier Source: org_study_id