Axial Spondyloarthritis, Psoriatic Arthritis
Conditions
Keywords
Bimekizumab, BKZ, Phase 1B
Brief summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Interventions
DRUGBimekizumab regimen 1 iv
Participants will receive bimekizumab (BKZ) at pre-specified time points.
DRUGBimekizumab regimen 2 iv
Participants will receive bimekizumab (BKZ) at pre-specified time points.
DRUGBimekizumab regimen 3 sc
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be 18+ years old and legally able to consent 2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment 3. Weigh between 45-100 kg (females) or 50-100 kg (males). 4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Exclusion criteria
1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro) 2. Severe psychiatric issues or substance abuse in the past year 3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB) 4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD)) 5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year) 6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady-state Trough Concentration (Ctrough,ss) at Week 16 | Week 16 | Steady-state trough concentration (Ctrough,ss) will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit | From Baseline to the end of SFU Visit (up to Week 29) | 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. |
| Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit | From Baseline to the end of SFU Visit (up to Week 29) | 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. |
| Occurrence of TEAEs leading to withdrawal of study intervention | From Baseline to the end of SFU Visit (up to Week 29) | 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. |
Countries
Bulgaria, Czechia, Germany, Poland, Slovakia, United States
Contacts
CONTACTUCB Cares
STUDY_DIRECTORUCB Cares
001 844 599 22733 (UCB)
Outcome results
None listed