A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUCB Biopharma SRL
About this trial
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be 18+ years old and legally able to consent
Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
Weigh between 45-100 kg (females) or 50-100 kg (males).
Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Disqualifiers
Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
Severe psychiatric issues or substance abuse in the past year
Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
Trial design
Design model
Parallel
Treatments tested in this trial
Bimekizumab regimen 1 iv
DrugParticipants will receive bimekizumab (BKZ) at pre-specified time points.
Bimekizumab regimen 2 iv
DrugParticipants will receive bimekizumab (BKZ) at pre-specified time points.
Bimekizumab regimen 3 sc
DrugParticipants will receive bimekizumab (BKZ) at pre-specified time points.
Treatment groups
392 Participants
are divided into 2 treatment groupsGroup A: Bimekizumab arm 1Experimental treatment 2 interventions
Group B: Bimekizumab arm 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Steady-state Trough Concentration (Ctrough,ss) at Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
Time frame
Week 16Secondary outcomes
1
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)2
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)3
Occurrence of TEAEs leading to withdrawal of study intervention
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)Sponsors and contacts
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Source ClinicalTrials.gov