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

Launched by UCB BIOPHARMA SRL · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called bimekizumab to see how well it works compared to an existing treatment called ustekinumab for children and teenagers aged 6 to under 18 who have moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches. The main goal of the study is to find out if bimekizumab is effective and safe for young patients with this condition.

To be eligible for the study, participants must have had moderate to severe plaque psoriasis for at least three months and have a certain level of skin involvement. They should weigh at least 15 kg and not have had a poor response to other specific psoriasis treatments. Participants will receive bimekizumab or ustekinumab through injections. Throughout the trial, they will be monitored for their skin condition and any side effects from the treatments. If you’re considering enrolling your child in this study, it's important to discuss it with their doctor to understand the potential benefits and risks.

Gender

ALL

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