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)

UCB

Status and phase: Enrolling; Phase 3

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: ustekinumab; Drug: bimekizumab; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06425549

PS0021

U1111-1293-2383 (Other Identifier)

2023-503859-10-00 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 168 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

168 participants in 2 patient groups

bimekizumab

Experimental group

Description:

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).

Treatment:

Drug: placebo

Drug: bimekizumab

ustekinumab

Active Comparator group

Description:

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.

Treatment:

Drug: placebo

Drug: bimekizumab

Drug: ustekinumab