Clinical trial NCT03895385: A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BKZ
UCB4940
Healthy Subjects
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Seroconversion response
timeFrame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
measure: Plasma concentration of bimekizumab (BKZ)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Incidence of Adverse Events (AE) from Baseline to Safety Follow Up
timeFrame: From Baseline to Safety Follow Up (up to Day 140)
Secondary outcomes:
measure: Influenza antibody geometric mean titers (GMT)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Area under the BKZ plasma concentration-time curve over the first 14 days AUC(0-14)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14)
measure: Area under the BKZ plasma concentration-time curve over the first 28 days AUC(0-28)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28)
measure: Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Maximum observed BKZ plasma drug concentration (Cmax)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
measure: Apparent terminal half-life (t1/2)
timeFrame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Up0034 001
state: Texas
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: