About this trial
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Bimekizumab
DrugBimekizumab will be administered at pre-specified timepoints.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
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.
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.
Sponsors and contacts
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