A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Randomized, Parallel-Group, Single-Dose Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Bimekizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female aged ≥18 years and ≤55 years at the Screening Visit Subject must have a blood test with at least two influenza antibody titers ≤1/10 at the Screening Visit and have not developed any flu-like illness 2 weeks before the start of the study Female subjects of childbearing potential must not be lactating and have a negative serum pregnancy test at the Screening Visit, which is confirmed to be negative by urine testing prior to administration of bimekizumab. Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 20 weeks after their last dose of the investigational medicinal product (IMP) Subject has a body weight of ≥45 kg and body mass index (BMI) between 18 and 32 kg/m2 (inclusive), at the Screening Visit Exclusion Criteria: Subject has a known hypersensitivity to any excipients of bimekizumab Subject has a history of hypersensitivity to the influenza vaccine Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method Male subjects who are planning a partner pregnancy during the study Subjects receiving vaccination of any kind within the 52 weeks prior to the Screening Visit or the influenza vaccination within 2 years prior to the Screening Visit. Live vaccines are not allowed during the study or for 20 weeks after the last dose of investigational medicinal product (IMP) Subject has a current or past history of gastrointestinal ulceration or other gastrointestinal disease, such as inflammatory bowel disease Subject has an active infection Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection or human T-cell lymphotropic virus type-1 (HTLV-1)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimekizumab<br>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. | Drug: Bimekizumab<br>* Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.<br>* Other names: UCB4940;|
| No Intervention: No Treatment<br>Subjects randomized to this arm will receive the influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BKZ, UCB4940, Healthy Subjects