- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895385
A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
September 16, 2020 updated by: UCB Biopharma S.P.R.L.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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San Antonio, Texas, United States, 78209
- Up0034 001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bimekizumab
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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Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
Other Names:
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NO_INTERVENTION: No Treatment
Subjects randomized to this arm will receive the influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroconversion response
Time Frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
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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.
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From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
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Plasma concentration of bimekizumab (BKZ)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Bimekizumab plasma concentrations by scheduled sampling time.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Incidence of Adverse Events (AE) from Baseline to Safety Follow Up
Time Frame: From Baseline to Safety Follow Up (up to Day 140)
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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.
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From Baseline to Safety Follow Up (up to Day 140)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the BKZ plasma concentration-time curve from time zero to last quantifiable concentration (AUCt)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Time of occurrence of the maximum observed BKZ plasma drug concentration (tmax)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Tmax is the time to reach maximum plasma concentration.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Influenza antibody geometric mean titers (GMT)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Post-vaccination influenza antibody geometric mean titers.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Area under the BKZ plasma concentration-time curve over the first 14 days AUC(0-14)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14)
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The AUC(0-14) is the area under the plasma concentration-time curve from time zero to day 14.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 14)
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Area under the BKZ plasma concentration-time curve over the first 28 days AUC(0-28)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28)
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The AUC(0-28) is the area under the plasma concentration-time curve from time zero to day 28.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 28)
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Area under the BKZ plasma concentration-time curve from time zero to infinity (AUC)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Maximum observed BKZ plasma drug concentration (Cmax)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Apparent terminal half-life (t1/2)
Time Frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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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.
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From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 2, 2019
Primary Completion (ACTUAL)
October 4, 2019
Study Completion (ACTUAL)
October 4, 2019
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (ACTUAL)
March 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 17, 2020
Last Update Submitted That Met QC Criteria
September 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UP0034
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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