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
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
3 other identifiers
interventional
40
6 countries
23
Brief Summary
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2025
Longer than P75 for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
March 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
February 27, 2026
February 1, 2026
3.1 years
October 30, 2024
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma bimekizumab concentrations over the Initial Treatment Period
Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period.
Up to Week 16
Secondary Outcomes (20)
Incidence of Treatment-emergent adverse events (TEAEs)
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of Serious TEAEs
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of TEAEs leading to discontinuation of investigational medicinal product (IMP)
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of TEAEs leading to withdrawal from the study
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions)
From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
- +15 more secondary outcomes
Study Arms (1)
Bimekizumab
EXPERIMENTALStudy participants will receive a bimekizumab dose which is dependent on their weight.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2024
First Posted
October 31, 2024
Study Start
March 11, 2025
Primary Completion (Estimated)
April 12, 2028
Study Completion (Estimated)
July 31, 2030
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.