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NCT06425549 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Moderate to Severe Plaque Psoriasis, sponsored by UCB Biopharma SRL.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
- 20
- Study locations
NCT06425549: Recruiting Phase 3 study of Moderate to Severe Plaque Psoriasis, sponsored by UCB Biopharma SRL.
NCT06425549 is a Phase 3 study of Moderate to Severe Plaque Psoriasis that is actively recruiting participants, run by UCB Biopharma SRL. The registered enrollment target is 168 participants, above the 50-participant average among 3 other Moderate to Severe Plaque Psoriasis trials with a reported enrollment target (236% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06425549, a Phase 3 study of Moderate to Severe Plaque Psoriasis, is actively recruiting participants, sponsored by UCB Biopharma SRL.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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
Conditions Studied
Interventions
- DRUG placebo
- DRUG bimekizumab
- DRUG ustekinumab
Study Locations (20)
Other
- Ps0021 40121 - Brussels
- Ps0021 40420 - Liège
- Ps0021 50618 - Mississauga
- Ps0021 50357 - St. John's
- Ps0021 50617 - St. John's
- Ps0021 40748 - Plzen-bory
- Ps0021 40742 - Argenteuil
- Ps0021 40754 - Nantes
- Ps0021 40740 - Bad Bentheim
- Ps0021 40515 - Berlin
- Ps0021 40138 - Bonn
California
- Ps0021 50162 - Fountain Valley
- Ps0021 50161 - Los Angeles
- Ps0021 50196 - Northridge
Texas
- Ps0021 50201 - Arlington
- Ps0021 50355 - Dallas
Florida
- Ps0021 50581 - Miami
Indiana
- Ps0021 50344 - Indianapolis
New York
- Ps0021 50599 - Kew Gardens
South Carolina
- Ps0021 50084 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2024-06-25 |
| Est. Completion | 2030-11-08 |
| Phase | Phase 3 |
What NCT06425549 shows while recruiting
NCT06425549 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 50-participant average among 3 other Moderate to Severe Plaque Psoriasis trials with a reported enrollment target (236% higher).
The record links to 1 condition, with Moderate to Severe Plaque Psoriasis appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT06425549 names 20 study sites across 7 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06425549 about?
NCT06425549 is a clinical study titled "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". 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).
What is the current status of trial NCT06425549?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2024-06-25. Estimated completion is 2030-11-08.
What conditions does trial NCT06425549 study?
This clinical trial studies the following conditions: Moderate to Severe Plaque Psoriasis.
What interventions are being tested in trial NCT06425549?
The interventions under investigation include: placebo (DRUG), bimekizumab (DRUG), ustekinumab (DRUG).
Who is sponsoring clinical trial NCT06425549?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06425549 being conducted?
This trial has 20 study locations across California, Florida, Indiana, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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