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Taking people in SpainPhase 3

Tests bimekizumab in children with enthesitis-related arthritis or juvenile psoriatic arthritis

Studies how bimekizumab moves through the body in children with juvenile arthritis.

Key facts

Who runs it
UCB Biopharma SRL
Where
Esplugues De Llobregat, Madrid, and Valencia, SpainSee the 3 sitesAlso in 5 other countries, 20 sites
Trial code
Registry 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
Status
Recruiting
Phase
Phase 3
People taking part
40 people, planned
Started
11 Mar 2025
Expected to end
31 Jul 2030
Type of study
Interventional
Treatments tested
  • Bimekizumab
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with active enthesitis-related arthritis or juvenile psoriatic arthritis who did not respond well enough to, or could not tolerate, an NSAID.

Age
2 to under 18 years
Sex
Boys and girls can join.
Disease stage
Enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and/or juvenile psoriatic arthritis for at least 3 months. The disease must be active: at least 3 active joints, and for enthesitis-related arthritis at least 1 site of enthesitis at baseline or in the history.
Earlier treatment
Inadequate response (at least 1 month) or intolerance to at least 1 NSAID. Methotrexate or sulfasalazine may continue at a stable dose, but they are not required. No other second-line disease-modifying or immunosuppressive drugs. No earlier bimekizumab or other IL-17 treatment, and no more than one earlier biologic other than an IL-17.

Main reasons for not taking part

  • Any other type of juvenile idiopathic arthritis
  • History of inflammatory bowel disease or signs of it
  • Active uncontrolled uveitis
  • Active tuberculosis, or latent tuberculosis that was not treated
  • Active suicidal thoughts or behavior, or severe depression in the past 6 months

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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:; Not a woman of childbearing potential (WOCBP) OR; 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

Who cannot take part

  • 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 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)
  • Study participant has history of inflammatory bowel disease (IBD) or signs/symptoms suggestive of IBD
  • Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated
  • Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
  • Study participant has laboratory abnormalities at Screening defined in the Protocol
  • 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 active uncontrolled uveitis
  • Presence of active suicidal ideation, or positive suicide behavior
  • Study participant has been diagnosed with severe depression in the past 6 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 18 years old?

Where in Spain

Also in 5 other countries, 20 sites

  • Sant Joan De Deu Barcelona HospitalEsplugues De Llobregat, SpainTaking people
  • Hospital Universitario Ramón y CajalMadrid, SpainTaking people
  • Hospital Universitario Y Politecnico La FeValencia, SpainTaking people

About the trial

What the trial wants to find out

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

The group in the trial

  • BimekizumabTreatment being tested

    Study participants will receive a bimekizumab dose which is dependent on their weight.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Tests bimekizumab in children with enthesitis-related arthritis or juvenile psoriatic arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06668181, who can take part
Record updated
23 October 2026