Bimekizumab vs. Ustekinumab for Plaque Psoriasis in Children and Adolescents
This study is looking at how well two medications, bimekizumab and ustekinumab, work to treat moderate to severe plaque psoriasis in children and adolescents aged 6 to less than 18 years. Plaque psoriasis is a skin condition that causes red, scaly patches. Participants will receive either bimekizumab, ustekinumab, or a placebo (an inactive substance) through injections under the skin. Researchers want to see if bimekizumab is more effective than ustekinumab in clearing up psoriasis. Success will be measured by how much the psoriasis improves by Week 16, specifically looking at the Psoriasis Area Severity Index (PASI90) and the Investigator's Global Assessment (IGA) scores. The study aims to enroll 168 participants.
- Study design
- This is an interventional study comparing bimekizumab to ustekinumab and a placebo. It plans to enroll 168 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at Week 16.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
42 sites across 13 statesStudy leadership
- UCB Cares · STUDY_DIRECTOR · 001 844 599 2273
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Psoriasis Area Severity Index 90 (PASI90) response at Week 16Week 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.
- Investigator´s Global Assessment (IGA) 0/1 response at Week 16Week 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.