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 (BE TOGETHER)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: bimekizumab; Drug: placebo; Drug: ustekinumab

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 1-844-599-2273 (USA); Email: ucbcares@ucb.com
• Study Contact Backup: Name: UCB Cares; Phone Number: 001 844 599 2273; Email: ucbcares@ucb.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Ps0021 50161
    • Northridge, California, United States, 91325
      • Recruiting
      • Ps0021 50196
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Ps0021 50344

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: bimekizumab; Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.; Other Names: UCB4940; BKZ; Drug: placebo; Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.
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.	Drug: bimekizumab; Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.; Other Names: UCB4940; BKZ; Drug: placebo; Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.; Drug: ustekinumab; Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.; Other Names: USTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area Severity Index 90 (PASI90) response at Week 16	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 16
Investigator´s Global Assessment (IGA) 0/1 response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI75 response at Week 4	The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 4
PASI100 response at Week 16	A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 16
PASI90 response at Week 48	The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 48
IGA 0/1 response at Week 48	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA response (Clear or Almost Clear) is defined as clear [0] or almost clear [1] with at least a two-category improvement from Baseline.	Week 48
PASI100 response at Week 48	A PASI100 responder is defined as a subject that achieves 100% reduction from Baseline in the PASI score. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.	Week 48
IGA 0 response at Week 16	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.	Week 16
IGA 0 response at Week 48	The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; post-inflammatory hyperpigmentation may be present, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild, just detectable to mild thickening; pink to light red coloration; predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red; moderate scaling and 4= severe, severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions. IGA 0 response (Clear) is defined as clear [0] with at least a two-category improvement from Baseline.	Week 48
Incidence of treatment-emergent adverse events (TEAE)s	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.	From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of serious TEAEs	An serious adverse event (SAE) must meet 1 or more of the following criteria: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent disability/incapacity; Is a congenital anomaly/birth defect; Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks.	From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs leading to discontinuation of Investigational Medicinal Product (IMP)	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.	From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs leading to withdrawal from the study	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP through the final dose of IMP + 20 weeks. This measure considers any TEAE leading to permanent withdrawal from study.	From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)
Incidence of TEAEs predefined as safety topics of interest	Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions.	From Baseline (Week 0) to Week 48 and to End of Safety Follow-up (up to Week 164)
Change from Baseline in vital signs (systolic blood pressure)	Blood pressure will be measured in millimeters of mercury (mmHg).	From Baseline (Week 0) up to Week 48
Change from Baseline in vital signs (diastolic blood pressure)	Blood pressure will be measured in millimeters of mercury (mmHg).	From Baseline (Week 0) up to Week 48
Change from Baseline in vital signs (pulse rate)	Pulse rate will be measured in beats per minute (beats/min).	From Baseline (Week 0) up to Week 48
Incidence of clinically significant physical examination findings reported as TEAEs	Clinically significant findings or worsening of previous findings since the physical examination at Baseline will be reported as TEAEs.	From Baseline (Week 0) up to Week 48
Change from Baseline in height (growth assessment)	Growth assessment, as assessed by the change from Baseline in height.	From Baseline (Week 0) up to Week 48
Change from Baseline in weight (growth assessment)	Growth assessment, as assessed by the change from Baseline in weight.	From Baseline (Week 0) up to Week 48.
Change from Baseline in hematology parameters (platelet count)	Platelets will be measured in number of platelets per liter (10^9/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (erythrocytes)	Erythrocytes will be measured in number of red blood cells per liter (10^12/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (hemoglobin)	Hemoglobin will be measured in grams per liter (g/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (hematocrit)	Hematocrit will be measured in volume percentage (%) of red blood cells in blood.	From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase)	Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in hematology parameters (basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes)	Basophils, eosinophils, lymphocytes, monocytes, neutrophils and leukocytes will be measured in number of white blood cells per liter (10^9/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium)	Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine)	Clinical chemistry parameters will be measured in micromols per liter (μmol/L).	From Baseline (Week 0) up to Week 48
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 16	The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).	Week 16, compared to Baseline
Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) total score at Week 48	The CDLQI is a questionnaire designed to measure the impact of skin diseases on the lives of children. The questionnaire consists of 10 questions that are based on the experiences of children with skin disease. The instrument asks participants about symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. The questions relate to the impact of the skin disease on the child over the last week. The CDLQI total score ranges from 0 to 30 with higher scores indicating higher impact of skin disease on quality of life (Qol).	Week 48, compared to Baseline
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) disability index at Week 16 for study participants with juvenile PsA prior to Baseline	The CHAQ is a questionnaire designed to capture physical function in children and adolescents with juvenile rheumatoid arthritis. The CHAQ comprises 2 indices, Disability and Discomfort. The Disability Index assesses the degree of difficulty experienced over the past week across 30 items in the following 8 categories of the daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The Disability Index ranges from 0 (no disability) to 3 (maximum disability). Discomfort is determined by the presence of pain, as measured by a 100-mm visual analogue scale (VAS). In addition, a final global assessment item asks study participants to rate how they are doing by placing a mark on a 100 mm VAS.	Week 16, compared to Baseline
Change from Baseline in Peak Pruritus numerical rating scale (NRS) score at Week 16	The Peak Pruritus NRS measures the worst level of itching in the past 24 hours on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch).	Week 16, compared to Baseline
Plasma bimekizumab concentrations prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period	Plasma bimekizumab concentrations prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration	From Baseline to End of OLE Period (up to 144 weeks)
Plasma anti-bimekizumab antibodies prior to and following IMP administration over the Initial Treatment Period, over the Maintenance Period, and over the OLE Period	Anti-bimekizumab antibody (AbAb) detection prior to investigational medicinal product (IMP) administration and following investigational medicinal product (IMP) administration	From Baseline to End of OLE Period (up to 144 weeks)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Estimated): June 7, 2024
• Primary Completion (Estimated): August 21, 2028
• Study Completion (Estimated): November 8, 2030

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Psoriasis; children; adolescents; Plaque Psoriasis; Pediatric Psoriasis; PSO; ustekinumab; BKZ; bimekizumab; paediatric study participants; Paediatric Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: PS0021; U1111-1293-2383 (Other Identifier: WHO universal trial number (UTN)); 2023-503859-10-00 (Registry Identifier: CTIS (EU CT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if a determination is made that the data cannot be adequately anonymized.
• IPD Sharing Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No