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A study to learn how bimekizumab works in children and teenagers with moderate to severe plaque psoriasis
EU CTIS ID: 2023-503859-10-00
What this study is testing
To evaluate the efficacy of bimekizumab administered subcutaneous (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe plaque psoriasis (PSO)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.