Bimekizumab
DrugBimekizumab will be administered at pre-specified timepoints.
NCT Number: NCT06668181
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
Interested in participating?
Request Info2 year–18 year
All sexes
Interventional
Phase 3
Ja0005 50646, Calgary, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bimekizumab will be administered at pre-specified timepoints.
Time frame: Up to Week 16
Plasma samples will be collected at pre-specified timepoints for measurement of plasma bimekizumab concentrations over the Initial Treatment Period.
Time frame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
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)
A SAE is defined as any untoward medical occurrence that, at any dose:
Time frame: From Baseline (Week 0) to End of Safety Follow-up (up to 141 weeks)
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)
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)
Safety topics of interest are infections (serious, opportunistic, fungal, and tuberculosis), inflammatory bowel disease, and injection site reactions.
Time frame: Baseline and Week 16
Blood pressure will be measured in millimeters of mercury (mmHg).
Time frame: Baseline and Week 16
Heart rate will be measured in beats per minute (beats/min).
Time frame: Baseline and 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
Glucose, potassium, sodium and calcium will be measured in millimoles per liter (mmol/L).
Time frame: Baseline and Week 16
Biochemistry parameters will be measured in micromols per liter (μmol/L).
Time frame: Baseline and Week 16
Hemoglobin will be measured in grams per liter (g/L).
Time frame: Baseline and Week 16
Hematocrit will be measured in volume percentage (%) of red blood cells in blood.
Time frame: Baseline and Week 16
Erythrocytes will be measured in number of red blood cells per liter (10^12/L).
Time frame: Baseline and 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
Growth assessment, as assessed by the change from Baseline in height will be measured in centimeters (cm).
Time frame: Baseline and Week 16
Growth assessment, as assessed by the change from Baseline in weight will be measured in kilograms (kg).
Time frame: Week 0 to Week 16
Incidence rate of injection site pain AEs during the ITP will be reported.
Time frame: 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:
Time frame: Baseline and Week 16
The JADAS27-hs-CRP is a composite disease activity score based on 4 core measures:
Time frame: Up to Week 16
Anti-bimekizumab antibody and neutralizing antibody detection prior to and following IMP administration during the Initial Treatment Period.
Contact information is provided by the study sponsor or research team.
UCB Biopharma SRL
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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