Actively Recruiting
Open-Label Study to Evaluate Pharmacokinetics and Safety of Bimekizumab in Children Ages 2 to Less Than 18 with Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis
Led by UCB Biopharma SRL · Updated on 2026-06-05
40
Participants Needed
23
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating plasma concentrations of bimekizumab in children and adolescents aged 2 to less than 18 years who have active juvenile idiopathic arthritis subtypes, specifically enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis. This Phase 3 open-label study aims to assess the pharmacokinetics and safety of bimekizumab in this pediatric population. The study is sponsored by UCB Biopharma SRL and focuses on understanding how the drug behaves in the body following administration. Participants will receive doses of bimekizumab based on their weight through subcutaneous injections at pre-specified times. The study includes an initial treatment period lasting up to 16 weeks, during which plasma bimekizumab levels will be measured. Following this period, safety follow-up will continue for up to 141 weeks to monitor any treatment-emergent adverse events, serious adverse events, and other safety concerns such as infections or injection site reactions. During the study, participants will undergo various assessments including blood tests to monitor vital signs, biochemistry, hematology, growth measures, and antibody responses related to bimekizumab. Disease activity will be evaluated using the Juvenile Arthritis Disease Activity Score and American College of Rheumatology pediatric response criteria. Participants and their caregivers can expect regular visits for these evaluations and safety monitoring throughout the initial and extended follow-up periods, with the total study duration potentially extending beyond two years.
CONDITIONS
Brief Title
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and less than 18 years at Baseline Visit
- Confirmed diagnosis of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and/or juvenile psoriatic arthritis for at least 3 months before Screening Visit
- Active disease with at least 3 active joints and at least 1 site of enthesitis at Baseline or documented by history
- Inadequate response or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID) for at least 1 month
- Stable use of methotrexate or sulfasalazine for at least 12 weeks prior, with no dose change 4 weeks before Baseline (optional)
- No use of second line agents other than methotrexate or sulfasalazine
- Body weight of at least 10 kg
- Male or female; females must not be pregnant or breastfeeding and must meet contraceptive requirements if of childbearing potential
- Capable of providing informed consent/assent through self or parent/legal guardian
You will not qualify if you...
- Diagnosed with juvenile idiopathic arthritis subtypes other than enthesitis-related arthritis or juvenile psoriatic arthritis
- History or signs of inflammatory bowel disease (IBD)
- Active uncontrolled uveitis
- History of active or latent tuberculosis unless successfully or prophylactically treated
- Major surgery within 3 months before Baseline or planned within 6 months after study start
- Laboratory abnormalities at Screening as defined in the protocol
- Active infection or history of serious, chronic, opportunistic, or unusually severe infections
- Use of prohibited drugs outside specified timeframes or prohibited concomitant treatments
- Previous treatment with bimekizumab or other IL-17 biologic response modifiers
- Prior treatment with more than one biologic response modifier other than IL-17
- Presence of active suicidal ideation or suicidal behavior
- Diagnosis of severe depression within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive bimekizumab doses at pre-specified timepoints based on their weight to treat active juvenile idiopathic arthritis subtypes enthesitis-related arthritis and juvenile psoriatic arthritis.
Multiple visits during the initial 16-week treatment period
Duration - Up to 141 weeks after baseline
Participants are monitored for safety including treatment-emergent adverse events and other health assessments up to 141 weeks after baseline.
Periodic visits for safety follow-up
Trial Site Locations
Total: 23 locations
1
Ja0005 50646
Calgary, Canada
Actively Recruiting
2
Ja0005 50644
Montreal, Canada
Actively Recruiting
3
Ja0005 50645
Saskatoon, Canada
Actively Recruiting
4
Ja0005 40777
Indre-et-Loire, France
Actively Recruiting
5
Ja0005 40510
Le Kremlin-Bicêtre, France
Actively Recruiting
6
Ja0005 40778
Paris, France
Actively Recruiting
7
Ja0005 40776
Poitiers, France
Actively Recruiting
8
Ja0005 40369
Berlin, Germany
Actively Recruiting
9
Ja0005 40356
Dresden, Germany
Actively Recruiting
10
Ja0005 40072
Freiburg im Breisgau, Germany
Active, Not Recruiting
11
Ja0005 40852
Hamburg, Germany
Actively Recruiting
12
Ja0005 40787
Sankt Augustin, Germany
Active, Not Recruiting
13
Ja0005 40779
Sendenhorst, Germany
Active, Not Recruiting
14
Ja0005 40427
Tübingen, Germany
Actively Recruiting
15
Ja0005 40720
Krakow, Poland
Actively Recruiting
16
Ja0005 40780
Sosnowiec, Poland
Active, Not Recruiting
17
Ja0005 40781
Esplugues de Llobregat, Spain
Actively Recruiting
18
Ja0005 40100
Madrid, Spain
Actively Recruiting
19
Ja0005 40782
Valencia, Spain
Actively Recruiting
20
Ja0005 40786
Bristol, United Kingdom
Active, Not Recruiting
21
Ja0005 40783
Manchester, United Kingdom
Actively Recruiting
22
Ja0005 40785
Nottingham, United Kingdom
Actively Recruiting
23
Ja0005 40784
Stroke-on-trent, United Kingdom
Active, Not Recruiting
Research Team
U
UCB Cares
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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