Clinical trial NCT06425549: 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
Official 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 Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: bimekizumab
BKZ
ustekinumab
paediatric study participants
children
adolescents
Psoriasis
PSO
Plaque Psoriasis
Paediatric Psoriasis
Pediatric Psoriasis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 168
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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:

  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:

* 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 1 biologic response modifier other than an IL-17
* 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

Primary outcomes:
measure: Psoriasis Area Severity Index 90 (PASI90) response at Week 16
timeFrame: Week 16
measure: Investigator´s Global Assessment (IGA) 0/1 response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: PASI75 response at Week 4
timeFrame: Week 4
measure: PASI100 response at Week 16
timeFrame: Week 16
measure: PASI90 response at Week 48
timeFrame: Week 48
measure: IGA 0/1 response at Week 48
timeFrame: Week 48
measure: PASI100 response at Week 48
timeFrame: Week 48
measure: IGA 0 response at Week 16
timeFrame: Week 16
measure: IGA 0 response at Week 48
timeFrame: Week 48
measure: Incidence of treatment-emergent adverse events (TEAE)s
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
measure: Incidence of serious TEAEs
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
measure: Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP)
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
measure: Incidence of TEAEs leading to withdrawal from the study
timeFrame: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
measure: Incidence of TEAEs predefined as safety topics of interest
timeFrame: From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164)
measure: Change from Baseline in vital signs (systolic blood pressure)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in vital signs (diastolic blood pressure)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in vital signs (pulse rate)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Incidence of clinically significant physical examination findings reported as TEAEs
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in height (growth assessment)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in weight (growth assessment)
timeFrame: From Baseline (Week 0) up to Week 48.
measure: Change from Baseline in hematology parameters (platelet count)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in hematology parameters (erythrocytes)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in hematology parameters (hemoglobin)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in hematology parameters (hematocrit)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine)
timeFrame: From Baseline (Week 0) up to Week 48
measure: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16
timeFrame: Week 16, compared to Baseline
measure: Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48
timeFrame: Week 48, compared to Baseline
measure: Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline
timeFrame: Week 16, compared to Baseline
measure: Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16
timeFrame: Week 16, compared to Baseline
measure: Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
timeFrame: From Baseline to End of OLE Period (up to 144 weeks)
measure: Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period
timeFrame: From Baseline to End of OLE Period (up to 144 weeks)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Ps0021 50162
state: California
city: Los Angeles
country: United States
facility: Ps0021 50161
state: California
city: Northridge
country: United States
facility: Ps0021 50196
state: California
city: Miami
country: United States
facility: Ps0021 50581
state: Florida
city: Indianapolis
country: United States
facility: Ps0021 50344
state: Indiana
city: Kew Gardens
country: United States
facility: Ps0021 50599
state: New York
city: Charleston
country: United States
facility: Ps0021 50084
state: South Carolina
city: Arlington
country: United States
facility: Ps0021 50201
state: Texas
city: Dallas
country: United States
facility: Ps0021 50355
state: Texas
city: Brussels
country: Belgium
facility: Ps0021 40121
city: Liege
country: Belgium
facility: Ps0021 40420
city: Mississauga
country: Canada
facility: Ps0021 50618
city: St- John's
country: Canada
facility: Ps0021 50617
city: St. John's
country: Canada
facility: Ps0021 50357
city: Plzen
country: Czechia
facility: Ps0021 40748
city: Argenteuil
country: France
facility: Ps0021 40742
city: Nantes
country: France
facility: Ps0021 40754
city: Bad Bentheim
country: Germany
facility: Ps0021 40740
city: Berlin
country: Germany
facility: Ps0021 40515
city: Bonn
country: Germany
facility: Ps0021 40138
city: Dresden
country: Germany
facility: Ps0021 40356
city: Erlangen
country: Germany
facility: Ps0021 40023
city: Frankfurt/main
country: Germany
facility: Ps0021 40645
city: Hamburg
country: Germany
facility: Ps0021 40758
city: Kiel
country: Germany
facility: Ps0021 40249
city: Muenster
country: Germany
facility: Ps0021 40177
city: Debrecen
country: Hungary
facility: Ps0021 40746
city: Kaposvár
country: Hungary
facility: Ps0021 40744
city: Szeged
country: Hungary
facility: Ps0021 40745
city: Ancona, Località Torrette
country: Italy
facility: Ps0021 40440
city: Catania
country: Italy
facility: Ps0021 40749
city: Pisa
country: Italy
facility: Ps0021 40085
city: Roma
country: Italy
facility: Ps0021 40567
city: Nagoya
country: Japan
facility: Ps0021 20033
city: Bialystok
country: Poland
facility: Ps0021 40741
city: Lodz
country: Poland
facility: Ps0021 40625
city: Nowa Sól
country: Poland
facility: Ps0021 40091
city: Rzeszow
country: Poland
facility: Ps0021 40737
city: Szczecin
country: Poland
facility: Ps0021 40743
city: Wroclaw
country: Poland
facility: Ps0021 40334
city: Wroclaw
country: Poland
facility: Ps0021 40738
city: Alicante
country: Spain
facility: Ps0021 40750
city: Barcelona
country: Spain
facility: Ps0021 40159
city: Esplugues de Llobregat
country: Spain
facility: Ps0021 40751
city: Granada
country: Spain
facility: Ps0021 40752
city: Santiago de Compostela
country: Spain
facility: Ps0021 40753
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: