Enthesitis-related ArthritisPhase 3NCT06668181
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
A Phase 3 study testing Bimekizumab in people with Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis, run by UCB Biopharma SRL at 23 sites in 6 countries.
Trial summary
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
- What is being tested?
- Bimekizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 23 sitesin 6 countries
- Study dates
- 11 Mar 2025to 31 Jul 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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 join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
23 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
UCB Cares contact
23 sites in 6 countries
Germany7 sites, 7 recruiting
- Recruiting
Ja0005 40369
Berlin
- Recruiting
Ja0005 40356
Dresden
- Recruiting
Ja0005 40072
Freiburg im Breisgau
- Recruiting
Ja0005 40852
Hamburg
- Recruiting
Ja0005 40787
Sankt Augustin
- Recruiting
Ja0005 40779
Sendenhorst
- Recruiting
Ja0005 40427
Tübingen
France4 sites, 4 recruiting
- Recruiting
Ja0005 40777
Indre-et-Loire
- Recruiting
Ja0005 40510
Le Kremlin-Bicêtre
- Recruiting
Ja0005 40778
Paris
- Recruiting
Ja0005 40776
Poitiers
United Kingdom4 sites, 3 recruiting
- Recruiting
Ja0005 40786
Bristol
- Recruiting
Ja0005 40783
Manchester
- Recruiting
Ja0005 40785
Nottingham
- Completed
Ja0005 40784
Stoke-on-Trent
Canada3 sites, 3 recruiting
- Recruiting
Ja0005 50646
Calgary
- Recruiting
Ja0005 50644
Montreal
- Recruiting
Ja0005 50645
Saskatoon
Spain3 sites, 3 recruiting
- Recruiting
Ja0005 40781
Esplugues de Llobregat
- Recruiting
Ja0005 40100
Madrid
- Recruiting
Ja0005 40782
Valencia
Poland2 sites, 1 recruiting
- Withdrawn
Ja0005 40720
Krakow
- Recruiting
Ja0005 40780
Sosnowiec
About this study
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
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
- Being tested
- Bimekizumab
- Keywords
- Arthritis, Bimekizumab
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Bimekizumab will be administered at pre-specified timepoints.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab | Experimental | Study participants will receive a bimekizumab dose which is dependent on their weight. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 16
Secondary outcomes (20)
Incidence of Treatment-emergent adverse events (TEAEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of Serious TEAEs
A SAE is defined as any untoward medical occurrence that, at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent disability/incapacity
- Is a congenital anomaly/birth defect
- Important medical events
Measured: 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)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Incidence of TEAEs leading to withdrawal from the study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
Measured: 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)
Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions.
Measured: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
Change from Baseline in vital signs (systolic and diastolic blood pressure) at Week 16
Blood pressure will be measured in millimeters of mercury (mmHg).
Measured: Baseline and Week 16
Change from Baseline in vital signs (heart rate) at Week 16
Heart rate will be measured in beats per minute (beats/min).
Measured: Baseline and Week 16
Change from Baseline in biochemistry parameters (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase) at Week 16
Alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase will be measured in units per liter (U/L).
Measured: Baseline and Week 16
Change from Baseline in biochemistry parameters (glucose, potassium, sodium, calcium) at Week 16
Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L).
Measured: Baseline and Week 16
Change from Baseline in biochemistry parameters (total bilirubin and direct bilirubin, total protein, blood urea nitrogen, and creatinine) at Week 16
Biochemistry parameters will be measured in micromols per liter (μmol/L).
Measured: Baseline and Week 16
Change from Baseline in hematology parameters (hemoglobin) at Week 16
Hemoglobin will be measured in grams per liter (g/L).
Measured: Baseline and Week 16
Change from Baseline in hematology parameters (hematocrit) at Week 16
Hematocrit will be measured in volume percentage (%) of red blood cells in blood.
Measured: Baseline and Week 16
Change from Baseline in hematology parameters (erythrocytes) at Week 16
Erythrocytes will be measured in number of red blood cells per liter (10^12/L).
Measured: Baseline and Week 16
Change from Baseline in hematology parameters (platelets, leukocytes neutrophils, lymphocytes, eosinophils, basophils, and monocytes) at Week 16
Platelets, leukocytes, neutrophils, lymphocytes, eosinophils, basophils, and monocytes will be measured in number of white blood cells per liter (10^9/L).
Measured: Baseline and Week 16
Change from Baseline in growth assessments (height) at Week 16
Growth assessment, as assessed by the change from Baseline in height will be measured in centimeters (cm).
Measured: Baseline and Week 16
Change from Baseline in growth assessments (weight) at Week 16
Growth assessment, as assessed by the change from Baseline in weight will be measured in kilograms (kg).
Measured: Baseline and Week 16
Acceptability assessments by injection site pain adverse events (AEs) during the Initial Treatment Period (Week 0 to Week 16)
Incidence rate of injection site pain AEs during the ITP will be reported.
Measured: Week 0 to Week 16
American College of Rheumatology pediatric (ACR Pedi) 30/50/70/90/100 response at Week 16
ACR assessments are based on a 30%, 50%, 70%, 90%, 100% or greater improvement (for ACR Pedi 30/50/70/90/100 respectively) in at least 3 of the 6 core set measures with no more than 1 of the remaining worsened by >30%. The 6 core set measures are:
- Number of joints with active arthritis (joints with swelling not due to deformity or inactive synovitis, or joints with limitation of motion with pain, tenderness, or both)
- Number of joints with limitation of range of motion
- Physician's Global Assessment of Disease Activity
- CHAQ total score (Disability Index) completed by parent or caregiver
- Parent/caregiver global assessment of overall well being of study participant
- Acute phase reactant (hs-CRP)
Measured: Week 16
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS27) -high sensitivity C-reactive protein (hs-CRP) at Week 16
The JADAS27-hs-CRP is a composite disease activity score based on 4 core measures:
- Number of joints with active arthritis
- Physician's Global Assessment of Disease Activity
- Parent/caregiver global assessment of overall well being of study participant
- Acute phase reactant (hs-CRP); inflammation biomarker. The JADAS27-hs-CRP is calculated as the sum of the scores of the 4 components with a total score range of 0 to 57.
Measured: Baseline and Week 16
Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period
Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period.
Measured: Up to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start11 Mar 2025
- Primary completion12 Apr 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enthesitis-related ArthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668181
- Sponsor's protocol ID
- JA0005
- Other IDs
- U1111-1305-2292, 2023-508845-41, 2023
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.