A Phase 3 interventional study of Bimekizumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis, sponsored by UCB Biopharma SRL. Recruiting at 23 sites in 6 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 40 is below the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study participants will receive a bimekizumab dose which is dependent on their weight.
Drug: Bimekizumab
Bimekizumab will be administered at pre-specified timepoints.
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.
Time frame: Up to Week 16
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Week 16
Change from Baseline in hematology parameters (hemoglobin) at Week 16
Hemoglobin will be measured in grams per liter (g/L).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 16
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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 sharing details ↗ · www.vivli.org
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Apr 2028, 37 months after the start.
Of 36 phase 3 interventional studies under Arthritis, Juvenile, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 70. This study's planned 37 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Bimekizumab