Phase
Condition
Rash
Warts
Rosacea
Treatment
bimekizumab
ustekinumab
placebo
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant must be 6 to <18 years of age, inclusive, at the time of signingthe 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/chemotherapyand 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
Exclusion Criteria:
Primary failure (no response within 12 weeks) to 1 or more interleukin-17 (IL-17)biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR more than 1biologic response modifier other than an IL-17
Study participant has a presence of guttate, inverse, pustular, or erythrodermic PSOor other dermatological condition that may impact the clinical assessment of PSO
Study participant has a history of inflammatory bowel disease (IBD) or symptomssuggestive of IBD
History of active tuberculosis unless successfully treated, latent TB unlessprophylactically treated
Study participant has an active infection or history of infections (such as seriousinfection, chronic infections, opportunistic infections, unusually severeinfections)
Study participant has previously received bimekizumab
Study participant has previously received ustekinumab
Study participant has received drugs outside the specified timeframes relative tothe Baseline Visit or receives prohibited concomitant treatments
Study participant has the presence of active suicidal ideation, or positive suicidebehavior
Study participant diagnosed with severe depression in the past 6 months (prior toScreening) should be excluded
Study participant has a history of psychiatric inpatient hospitalization within thepast year before enrolling into the study
Study Design
Connect with a study center
Ps0021 40121
Brussels,
BelgiumSite Not Available
Ps0021 40121
Brussels 2800866,
BelgiumSite Not Available
Ps0021 40121
Bruxelles,
BelgiumSite Not Available
Ps0021 40420
Liege,
BelgiumSite Not Available
Ps0021 40420
Liège,
BelgiumSite Not Available
Ps0021 40420
Liège 2792413,
BelgiumSite Not Available
Ps0021 50618
Mississauga,
CanadaSite Not Available
Ps0021 50618
Mississauga 6075357,
CanadaSite Not Available
Ps0021 50617
St- John's,
CanadaSite Not Available
Ps0021 50357
St. John's,
CanadaSite Not Available
Ps0021 50617
St. John's,
CanadaSite Not Available
Ps0021 50357
St. John's 6324733,
CanadaSite Not Available
Ps0021 50617
St. John's 6324733,
CanadaActive - Recruiting
Ps0021 40748
Plzen,
CzechiaSite Not Available
Ps0021 40748
Plzen-bory,
CzechiaSite Not Available
Ps0021 40742
Argenteuil,
FranceSite Not Available
Ps0021 40742
Argenteuil 3037044,
FranceSite Not Available
Ps0021 40754
Nantes,
FranceSite Not Available
Ps0021 40754
Nantes 2990969,
FranceSite Not Available
Ps0021 40138
Adenau,
GermanySite Not Available
Ps0021 40740
Bad Bentheim,
GermanySite Not Available
Ps0021 40740
Bad Bentheim 2953552,
GermanySite Not Available
Ps0021 40515
Berlin,
GermanyCompleted
Ps0021 40515
Berlin 2950159,
GermanySite Not Available
Ps0021 40138
Bonn,
GermanySite Not Available
Ps0021 40138
Bonn 2946447,
GermanySite Not Available
Ps0021 40356
Dresden,
GermanySite Not Available
Ps0021 40356
Dresden 2935022,
GermanySite Not Available
Ps0021 40023
Erlangen,
GermanyCompleted
Ps0021 40023
Erlangen 2929567,
GermanySite Not Available
Ps0021 40645
Frankfurt am Main,
GermanySite Not Available
Ps0021 40645
Frankfurt am Main 2925533,
GermanySite Not Available
Ps0021 40645
Frankfurt/main,
GermanySite Not Available
Ps0021 40758
Hamburg,
GermanySite Not Available
Ps0021 40758
Hamburg 2911298,
GermanySite Not Available
Ps0021 40249
Kiel,
GermanySite Not Available
Ps0021 40249
Kiel 2891122,
GermanySite Not Available
Ps0021 40747
Mainz,
GermanyCompleted
Ps0021 40747
Mainz 2874225,
GermanySite Not Available
Ps0021 40177
Muenster,
GermanySite Not Available
Ps0021 40177
Münster,
GermanySite Not Available
Ps0021 40177
Münster 2867543,
GermanySite Not Available
Ps0021 40746
Debrecen,
HungarySite Not Available
Ps0021 40746
Debrecen 721472,
HungarySite Not Available
Ps0021 40744
Kaposvár,
HungarySite Not Available
Ps0021 40744
Kaposvár 3050616,
HungarySite Not Available
Ps0021 40745
Szeged,
HungarySite Not Available
Ps0021 40745
Szeged 715429,
HungarySite Not Available
Ps0021 40440
Ancona, Località Torrette,
ItalySite Not Available
Ps0021 40440
Ancona, Località Torrette 3183089,
ItalySite Not Available
Ps0021 40749
Catania,
ItalySite Not Available
Ps0021 40749
Catania 2525068,
ItalySite Not Available
Ps0021 40085
Pisa,
ItalySite Not Available
Ps0021 40085
Pisa 3170647,
ItalySite Not Available
Ps0021 40567
Roma,
ItalySite Not Available
Ps0021 40567
Roma 8957247,
ItalySite Not Available
Ps0021 40440
Torrette DI Ancona,
ItalySite Not Available
Ps0021 20071
Nagasaki,
JapanActive - Recruiting
Ps0021 20071
Nagasaki 1856177,
JapanSite Not Available
Ps0021 20033
Nagoya,
JapanActive - Recruiting
Ps0021 20033
Nagoya 1856057,
JapanSite Not Available
Ps0021 20337
Shimotsuga-gun,
JapanActive - Recruiting
Ps0021 40741
Bialystok,
PolandSite Not Available
Ps0021 40741
Bialystok 776069,
PolandSite Not Available
Ps0021 40625
Lodz,
PolandSite Not Available
Ps0021 40832
Lodz,
PolandSite Not Available
Ps0021 40625
Lodz 3093133,
PolandSite Not Available
Ps0021 40832
Lodz 3093133,
PolandSite Not Available
Ps0021 40091
Nowa Sol,
PolandSite Not Available
Ps0021 40091
Nowa Sól,
PolandSite Not Available
Ps0021 40091
Nowa Sól 3090764,
PolandSite Not Available
Ps0021 40737
Rzeszow,
PolandSite Not Available
Ps0021 40737
Rzeszów,
PolandSite Not Available
Ps0021 40737
Rzeszów 759734,
PolandSite Not Available
Ps0021 40743
Szczecin,
PolandSite Not Available
Ps0021 40743
Szczecin 3083829,
PolandSite Not Available
Ps0021 40625
Warsaw,
PolandSite Not Available
Ps0021 40625
Warsaw 756135,
PolandSite Not Available
Ps0021 40334
Wroclaw,
PolandSite Not Available
Ps0021 40738
Wroclaw,
PolandSite Not Available
Ps0021 40334
Wroclaw 3081368,
PolandSite Not Available
Ps0021 40738
Wroclaw 3081368,
PolandSite Not Available
Ps0021 40750
Alicante,
SpainSite Not Available
Ps0021 40750
Alicante 2521978,
SpainSite Not Available
Ps0021 40159
Barcelona,
SpainSite Not Available
Ps0021 40159
Barcelona 3128760,
SpainSite Not Available
Ps0021 40751
Esplugues de Llobregat,
SpainSite Not Available
Ps0021 40751
Esplugues de Llobregat 3122826,
SpainSite Not Available
Ps0021 40752
Granada,
SpainSite Not Available
Ps0021 40752
Granada 2517117,
SpainSite Not Available
Ps0021 40753
Santiago de Compostela,
SpainSite Not Available
Ps0021 40753
Santiago de Compostela 3109642,
SpainSite Not Available
Ps0021 50162
Fountain Valley, California 92708
United StatesSite Not Available
Ps0021 50161
Los Angeles, California 90045
United StatesSite Not Available
Ps0021 50196
Northridge, California 91325
United StatesCompleted
Ps0021 50162
Fountain Valley 5350207, California 5332921 92708
United StatesSite Not Available
Ps0021 50161
Los Angeles 5368361, California 5332921 90045
United StatesSite Not Available
Ps0021 50196
Northridge 5377985, California 5332921 91325
United StatesSite Not Available
Ps0021 50581
Miami, Florida 33165
United StatesSite Not Available
Ps0021 50581
Miami 4164138, Florida 4155751 33165
United StatesSite Not Available
Ps0021 50344
Indianapolis, Indiana 46250
United StatesSite Not Available
Ps0021 50344
Indianapolis 4259418, Indiana 4921868 46250
United StatesSite Not Available
Ps0021 50599
Kew Gardens, New York 11415
United StatesSite Not Available
Ps0021 50599
Kew Gardens 5123344, New York 5128638 11415
United StatesSite Not Available
Ps0021 50084
Charleston, South Carolina 29425
United StatesSite Not Available
Ps0021 50084
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Ps0021 50201
Arlington, Texas 76011
United StatesCompleted
Ps0021 50355
Dallas, Texas 75235
United StatesSite Not Available
Ps0021 50201
Arlington 4671240, Texas 4736286 76011
United StatesSite Not Available
Ps0021 50355
Dallas 4684888, Texas 4736286 75235
United StatesSite Not Available

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