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
NCT ID: NCT06668181
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2025-03-11
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bimekizumab
Study participants will receive a bimekizumab dose which is dependent on their weight.
Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Interventions
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Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Ja0005 50646
Calgary, , Canada
Ja0005 50644
Montreal, , Canada
Ja0005 50645
Saskatoon, , Canada
Ja0005 40777
Indre-et-Loire, , France
Ja0005 40510
Le Kremlin-Bicêtre, , France
Ja0005 40778
Paris, , France
Ja0005 40776
Poitiers, , France
Ja0005 40369
Berlin, , Germany
Ja0005 40356
Dresden, , Germany
Ja0005 40072
Freiburg im Breisgau, , Germany
Ja0005 40852
Hamburg, , Germany
Ja0005 40787
Sankt Augustin, , Germany
Ja0005 40779
Sendenhorst, , Germany
Ja0005 40427
Tübingen, , Germany
Ja0005 40720
Krakow, , Poland
Ja0005 40780
Sosnowiec, , Poland
Ja0005 40781
Esplugues de Llobregat, , Spain
Ja0005 40100
Madrid, , Spain
Ja0005 40782
Valencia, , Spain
Ja0005 40786
Bristol, , United Kingdom
Ja0005 40783
Manchester, , United Kingdom
Ja0005 40785
Nottingham, , United Kingdom
Ja0005 40784
Stroke-on-trent, , United Kingdom
Countries
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Central Contacts
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UCB Cares
Role: CONTACT
Other Identifiers
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U1111-1305-2292
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508845-41
Identifier Type: REGISTRY
Identifier Source: secondary_id
JA0005
Identifier Type: -
Identifier Source: org_study_id
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