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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508845-41-00
Acronym
JA0005
Enrollment
28
Registered
2024-10-14
Start date
2025-03-11
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active juvenile idiopathic arthritis subtypes enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis

Brief summary

Plasma bimekizumab concentrations over the Initial Treatment Period

Detailed description

Occurrence of Treatment-emergent adverse events (TEAEs), Occurrence of Serious TEAEs, Occurrence of TEAEs leading to discontinuation of investigational medicinal product (IMP), Occurrence of TEAEs leading to withdrawal from the study, Occurrence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions), Change from Baseline in vital signs (systolic blood pressure) at Week 16, Change from Baseline in vital signs (diastolic blood pressure) at Week 16, Change from Baseline in vital signs (heart rate) at Week 16, Change from Baseline in protocol planned laboratory analyses (chemistry) at Week 16, Change from Baseline in protocol planned laboratory analyses (hematology) at Week 16, Change from Baseline in growth assessments (height) at Week 16, Change from Baseline in growth assessments (weight) at Week 16, Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16), American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16, Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16, Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period

Interventions

DRUGbimekizumab

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Plasma bimekizumab concentrations over the Initial Treatment Period

Secondary

MeasureTime frame
Occurrence of Treatment-emergent adverse events (TEAEs), Occurrence of Serious TEAEs, Occurrence of TEAEs leading to discontinuation of investigational medicinal product (IMP), Occurrence of TEAEs leading to withdrawal from the study, Occurrence of selected safety events of interest (including infection [serious, opportunistic, fungal, and tuberculosis (TB)], inflammatory bowel disease [IBD], and injection site reactions), Change from Baseline in vital signs (systolic blood pressure) at Week 16, Change from Baseline in vital signs (diastolic blood pressure) at Week 16, Change from Baseline in vital signs (heart rate) at Week 16, Change from Baseline in protocol planned laboratory analyses (chemistry) at Week 16, Change from Baseline in protocol planned laboratory analyses (hematology) at Week 16, Change from Baseline in growth assessments (height) at Week 16, Change from Baseline in growth assessments (weight) at Week 16, Acceptability assessments by injection site pain adverse event

Countries

France, Germany, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026