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

Phase 3RecruitingNCT06425549

UCB Biopharma SRL168 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

168

Conditions

Moderate to Severe Plaque Psoriasis

Interventions

bimekizumabDRUG

Study participants receive bimekizumab (BKZ) administered as subcutaneous injection at pre-specified timepoints and dosage regimen during the study.

ustekinumabDRUG

Study participants receive ustekinumab (USTE) administered as subcutaneous injection at pre-specified timepoints during the study.

placeboDRUG

Study participants receive placebo at pre-specified timepoints during the study to maintain the blinding.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (50)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 16

Secondary Outcomes

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.

Central Contacts

UCB Cares

CONTACT

1-844-599-2273 (USA)ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273 UCBCares@ucb.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Ps0021 50162

Fountain Valley, California, United States

ACTIVE_NOT_RECRUITING

Ps0021 50161

Los Angeles, California, United States

ACTIVE_NOT_RECRUITING

Ps0021 50196

Northridge, California, United States

COMPLETED

Ps0021 50581

Miami, Florida, United States

RECRUITING

Ps0021 50344

Indianapolis, Indiana, United States

ACTIVE_NOT_RECRUITING

Ps0021 50599

Kew Gardens, New York, United States

RECRUITING

Ps0021 50084

Charleston, South Carolina, United States

ACTIVE_NOT_RECRUITING

Ps0021 50201

Arlington, Texas, United States

ACTIVE_NOT_RECRUITING

Ps0021 50355

Dallas, Texas, United States

ACTIVE_NOT_RECRUITING

Ps0021 40121

Brussels, Belgium

ACTIVE_NOT_RECRUITING

...and 40 more locations

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.

Time frame: Week 16

PASI90 response at Week 48

Time frame: Week 48

IGA 0/1 response at Week 48

Time frame: Week 48

PASI100 response at Week 48

Time frame: 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.

Time frame: Week 16

IGA 0 response at Week 48

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: From Baseline (Week 0) to End of Safety Follow-up (up to Week 164)

Incidence of TEAEs leading to withdrawal from the study

Time frame: 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.

Time frame: 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).