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The purpose of the study is to evaluate whether administration of bimekizumab has an effect on the expected production of antibody titers to the influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | Subjects randomized to this arm will receive a single dose bimekizumab followed by inactivated influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period. |
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| No Treatment | No Intervention | Subjects randomized to this arm will receive the influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion response | A subject is considered as a seroconversion responder if the following is true: subject has either a pre-vaccination HI titer ≤1/10 and a 4-week post-vaccination HI titer ≥1/40 or a pre-vaccination HI titer >1/10 and a ≥4fold increase in HI titer 4 weeks after vaccination in at least 2 out of 4 serotypes. | From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43) |
| Plasma concentration of bimekizumab (BKZ) | Bimekizumab plasma concentrations by scheduled sampling time. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Incidence of Adverse Events (AE) from Baseline to Safety Follow Up | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | From Baseline to Safety Follow Up (up to Day 140) |
| Measure | Description | Time Frame |
|---|---|---|
| Influenza antibody geometric mean titers (GMT) | Post-vaccination influenza antibody geometric mean titers. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Area under the BKZ plasma concentration-time curve over the first 14 days AUC(0-14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0034 001 | San Antonio | Texas | 78209 | United States |
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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The AUC(0-14) is the area under the plasma concentration-time curve from time zero to day 14. |
| From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14) |
| Area under the BKZ plasma concentration-time curve over the first 28 days AUC(0-28) | The AUC(0-28) is the area under the plasma concentration-time curve from time zero to day 28. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28) |
| Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) | The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC) | The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/λz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Maximum observed BKZ plasma drug concentration (Cmax) | Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax) | Tmax is the time to reach maximum plasma concentration. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |
| Apparent terminal half-life (t1/2) | Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-λz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/λz. | From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140) |