The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS)
Study participant must be 12 to <18 years of age at the time of informed consent/assent, at Tanner stage 2 or more, for the first 8 participants only, followed by also including participants ≥9 to <18 years of age at Tanner stage 2 or more.
Study participant must have a diagnosis of HS for at least 6 months prior to the Baseline Visit.
Study participant must have moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, the sum of abscesses and inflammatory nodules), as assessed at both the Screening and Baseline Visits.
Study participant must have HS lesions present in at least 2 distinct anatomic areas, 1 of which must be at least Hurley Stage II or III, as assessed at both the Screening and Baseline Visits.
Study participant has a draining tunnel count of >20 at either the Screening or Baseline Visits.
Study participant has experienced primary failure (no response within 12 weeks) to 1 or more IL 17 biologic response modifiers (eg, brodalumab, ixekizumab, secukinumab) OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier.
Study participant has previously participated in this study or has received previous therapy with bimekizumab.
Study participant has a history of IBD or symptoms suggestive of IBD.
Single group
Bimekizumab
DrugBimekizumab will be administered at pre-specified timepoints.
Geometric Mean Plasma bimekizumab concentrations at Week 16
Plasma samples will be collected prior to dosing for measurement of plasma concentrations of bimekizumab at the specified timepoint.
Exposure-adjusted incidence rate of Treatment- Emergent Adverse Events (TEAEs) during the Initial Treatment Period
The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to IMP.
Exposure-adjusted incidence rate of Serious TEAEs during the Initial Treatment Period
The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. 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
Exposure-adjusted incidence rate of TEAEs leading to withdrawal during the Initial Treatment Period
The TEAEs adjusted by duration of exposure to study treatment are scaled such that it provides an incidence rate per 100 patient-years. If a participant has multiple events, the time of exposure will be calculated to first occurrence of the AE being considered. If a participant has no events, the total time at risk will be used. 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 IMP.
Exposure-adjusted incidence rate of Selected Safety Topics of Interest (including incidence of infections [serious, opportunistic, fungal, and TB], IBD, and injection site reactions) over the Initial Treatment Period
Safety topics of interest for this study include events for which special monitoring will be for infections (serious, opportunistic, fungal, and tuberculosis \[TB\]), inflammatory bowel disease (IBD), and injection site reactions.
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