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Evaluating Bimekizumab for Pediatric Arthritis

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

Phase 3 Interventional UCB Pharma · NCT06668181

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

PhasePhase 3
Study typeInterventional
Enrollment40 (estimated)
Ages2 Years to 18 Years
SexAll
SponsorUCB Pharma Industry-sponsored
Drugs / interventionsbimekizumab, methotrexate
Locations23 sites (Calgary and 22 other locations)
Trial IDNCT06668181 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies have shown promise in using bimekizumab for similar conditions, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Calgary and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Enthesitis-related ArthritisJuvenile Psoriatic ArthritisArthritisBimekizumab
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.