## PS0021

## 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

### 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).

### Medical Condition

Moderate to Severe Plaque Psoriasis

### Min. Age

6

Years

### Max. Age

17

Years

### Who Can Join?

All

### Status

Active, not recruiting

### 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: a) Body surface area (BSA) affected by PSO ≥10% b). Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4) c). 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 Medication Description

#### Study Medication:

Bimzelx®

#### Other Descriptive Name:

bimekizumab

#### Placebo

No

#### Comparator:

Yes

### Study Dates

### June 2024

Actual Start Date of Enrollment

### November 2030

Planned Study Completion Date

### General Information

Study ID:

PS0021

CT.gov Number:

[NCT06425549](https://clinicaltrials.gov/ct2/show/NCT06425549)

Phase:

Phase 3