To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
392
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Steady-state Trough Concentration (Ctrough,ss) at Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
Time frame: Week 16
Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention.
Time frame: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit
An SAE is any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other situations: Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention.
Time frame: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of TEAEs leading to withdrawal of study intervention
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. TEAEs leading to withdrawal of IMP of the study will be reported.
Time frame: From Baseline to the end of SFU Visit (up to Week 29)