Evaluating Bimekizumab for Pediatric Arthritis
Official title: Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Run by UCB Pharma · NCT06668181 · Data updated 2026-11-12
This study is testing a new medication called bimekizumab in children with certain types of arthritis to see if it is safe and effective for them.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | UCB Pharma Industry-sponsored |
| Drugs / interventions | bimekizumab, methotrexate |
| Locations | 23 sites (Calgary and 22 other locations) |
| Status | Recruiting |
| Started | March 11, 2025 |
| Main results expected | April 12, 2028 |
| Study ends | July 31, 2030 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06668181 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2 to under 18 years with a confirmed diagnosis of enthesitis-related arthritis or juvenile psoriatic arthritis and active disease.
✕Probably not a fit
Patients who do not have active disease or have not had an inadequate response to NSAIDs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the pharmacokinetics and safety of bimekizumab in children aged 2 to under 18 years with active enthesitis-related arthritis and juvenile psoriatic arthritis. Participants will receive subcutaneous bimekizumab and their plasma concentrations will be monitored to assess the drug's effectiveness and safety profile. The study aims to include children who have had an inadequate response to nonsteroidal anti-inflammatory drugs. The goal is to gather data that could inform future treatment options for these pediatric conditions.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for children suffering from specific types of juvenile arthritis.
How similar studies have gone: Other studies have shown promise in using bimekizumab for similar conditions, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study participant must be 2 to \<18 years of age inclusive, at the Baseline Visit. * Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit. * Study participants who have active disease (ERA \[including JAS\] and/or JPsA) defined as having at least 3 active joints, each of which needs to be included in the joints assessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline or documented by history. * Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID). * Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.) * Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs with the exception of methotrexate or sulfasalazine. * Body weight of ≥10kg. * Male and female. * A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period) * Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol. Exclusion Criteria: * Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and/or juvenile psoriatic arthritis (JPsA). * Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD. * Study participant has active uncontrolled uveitis. * Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated. * Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study. * Study participant has laboratory abnormalities at Screening defined in the Protocol. * Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections). * Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments. * Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier. * Study participant had prior treatment with more than one biologic response modifier (other than an IL-17). * Presence of active suicidal ideation, or positive suicide behavior. * Study participant has been diagnosed with severe depression in the past 6 months.
Where it's running
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Ja0005 50646
Calgary, Canada Recruiting -
Ja0005 50644
Montreal, Canada Recruiting -
Ja0005 50645
Saskatoon, Canada Recruiting -
Ja0005 40777
Indre-et-Loire, France Recruiting -
Ja0005 40510
Le Kremlin-Bicêtre, France Recruiting -
Ja0005 40778
Paris, France Recruiting
Show 17 more locations
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Ja0005 40776
Poitiers, France Recruiting -
Ja0005 40369
Berlin, Germany Recruiting -
Ja0005 40356
Dresden, Germany Recruiting -
Ja0005 40072
Freiburg im Breisgau, Germany Recruiting -
Ja0005 40852
Hamburg, Germany Recruiting -
Ja0005 40787
Sankt Augustin, Germany Recruiting -
Ja0005 40779
Sendenhorst, Germany Recruiting -
Ja0005 40427
Tübingen, Germany Recruiting -
Ja0005 40780
Sosnowiec, Poland Recruiting -
Ja0005 40781
Esplugues de Llobregat, Spain Recruiting -
Ja0005 40100
Madrid, Spain Recruiting -
Ja0005 40782
Valencia, Spain Recruiting -
Ja0005 40786
Bristol, United Kingdom Recruiting -
Ja0005 40783
Manchester, United Kingdom Recruiting -
Ja0005 40785
Nottingham, United Kingdom Recruiting -
Ja0005 40720
Krakow, Poland Withdrawn -
Ja0005 40784
Stoke-on-Trent, United Kingdom Completed
Study contacts
- Study coordinator: UCB Cares
- Email: ucbcares@ucb.com
- Phone: +18445992273
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Bimekizumab by IV infusion versus subcutaneous injection for adults with psoriatic arthritis or axial spondyloarthritis
This trial tests whether bimekizumab given by intravenous (IV) infusion behaves the same in the body as the usual subcutaneous injection in adults with psoriatic arthritis or axial spondyloarthritis.
-
Bimekizumab for palmoplantar pustulosis (PPP)
This trial tests whether bimekizumab helps adults with palmoplantar pustulosis and is safe compared with a placebo.
-
Comparing five advanced treatments for axial spondyloarthritis and psoriatic arthritis
This project will see how well bimekizumab, risankizumab, guselkumab, upadacitinib, or a TNF inhibitor work for adults with axSpA or PsA who have just started one of these medicines, using medical records and patient surveys.
-
Assessing Bimekizumab Levels in Breast Milk of Nursing Mothers
This study tests how much of the medication bimekizumab is found in the breast milk of mothers who have been using it for at least 12 weeks after giving birth to see if it's safe for their babies.
-
Evaluating Deucravacitinib for Juvenile Psoriatic Arthritis in Children
This study is testing if a new medication called Deucravacitinib can help children with juvenile psoriatic arthritis who haven't had success with other treatments.
-
Evaluating the safety and effectiveness of intravenous secukinumab in children with juvenile psoriatic arthritis.
This study is testing if an intravenous medication called secukinumab is safe and effective for children with juvenile psoriatic arthritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.