Actively Recruiting
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
Led by UCB Biopharma SRL · Updated on 2026-02-27
40
Participants Needed
23
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
CONDITIONS
Official 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 2 to less than 18 years at baseline visit
- Confirmed diagnosis of enthesitis-related arthritis (ERA) including juvenile-onset ankylosing spondylitis (JAS) and/or juvenile psoriatic arthritis (JPsA) for at least 3 months before screening
- Active disease with at least 3 active joints assessed by JADAS27 and at least 1 enthesitis site for ERA at baseline or documented history
- Inadequate response or intolerance to at least 1 NSAID for at least 1 month
- Stable methotrexate or sulfasalazine use allowed if taken for 12 weeks prior and stable for 4 weeks before baseline, with no dose changes for first 16 weeks
- No use of other disease-modifying or immunosuppressive drugs besides methotrexate or sulfasalazine
- Body weight of at least 10 kg
- Male or female
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and safety follow-up
- Ability to provide informed consent/assent with parent/legal representative
You will not qualify if you...
- Diagnosis of juvenile idiopathic arthritis categories other than ERA (including JAS) and/or JPsA
- History or signs of inflammatory bowel disease (IBD)
- Active uncontrolled uveitis
- History of active or latent tuberculosis unless successfully treated or prophylactically treated
- Major surgery within 3 months before baseline or planned major surgery within 6 months after study start
- Laboratory abnormalities defined by 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 therapy with bimekizumab or other IL-17 biologic response modifiers
- Prior treatment with more than one biologic response modifier other than IL-17
- Active suicidal ideation or positive suicide behavior
- Diagnosis of severe depression in past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively 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
CONTACT
U
UCB Cares
CONTACT
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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