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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895385
• Other study ID #: UP0034
• Status: Completed
• Phase: Phase 1
• Start date: April 2, 2019
• Est. completion date: October 4, 2019

Study information

• Verified date: September 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Bimekizumab
Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.

Locations

Country	Name	City	State
United States	Up0034 001	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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/?z, where Clast is the last quantifiable plasma concentration and ?z is the apparent terminal elimination rate constant.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Secondary	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)
Secondary	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)
Secondary	Apparent terminal half-life (t1/2)	Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-?z) 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/?z.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)