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Looking for participantsPhase3

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

Sponsor: UCB Biopharma SRL

NCT ID: NCT06668181

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Bimekizumab (drug)
How long the study runs
Study runs about 64 months (dates as stated)
About the drug or intervention
Bimekizumab — drug: Bimekizumab will be administered at pre-specified timepoints.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
2 Years to 18 Years
Who
All
Number of participants
40
Started
2025-03-11
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for enthesitis-related arthritis
  • • Phase3 - 40 participants
  • • The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration

Who can take part?

  • • Ages 2 Years to 18 Years
  • • Diagnosed with enthesitis-related arthritis

Where?

  • • Bristol - Ja0005 40786
  • • Manchester - Ja0005 40783
  • • Nottingham - Ja0005 40785
  • • Stoke-on-Trent - Ja0005 40784

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Enthesitis-related ArthritisJuvenile Psoriatic Arthritis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 2 Years - 18 Years
  • Who can join: All genders

Biomarkers mentioned

or positive

Treatment history

Treatments you must have had:

  • ✓ for study participation

What the study is looking for

  • ✓Study participant must be 2 to \<18 years of age inclusive, at the Baseline Visit.
  • ✓Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal...
  • ✓Study participants with no concomitant use of second line agents such as disease-modifying and/or immunosuppressive...
  • ✓Body weight of ≥10kg.
  • ✓Male and female.

Who cannot take part

  • ✗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...
  • ✗Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or...
  • ✗Study participant has laboratory abnormalities at Screening defined in the Protocol.
See the full 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 Is This Study? (4 UK sites)

Ja0005 40786

Bristol, United Kingdom

Recruiting

Ja0005 40783

Manchester, United Kingdom

Recruiting

Ja0005 40785

Nottingham, United Kingdom

Recruiting

Ja0005 40784

Stoke-on-Trent, United Kingdom

COMPLETED

How to Get in Touch

UCB Cares

Sponsor contact

CONTACT

+18445992273 ucbcares@ucb.com

UCB Cares

Sponsor contact

CONTACT

001 844 599 2273
Data sourced from ClinicalTrials.gov · Last verified: 2026-10