Healthy VolunteersPhase 1NCT03895385
A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
A Phase 1 study testing Bimekizumab in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bimekizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 4 Oct 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Bimekizumab
- Keywords
- BKZ, UCB4940, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Also called BKZ, UCB4940
Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bimekizumab |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Baseline to Safety Follow Up (up to Day 140)
Secondary outcomes (8)
Influenza antibody geometric mean titers (GMT)
Post-vaccination influenza antibody geometric mean titers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start2 Apr 2019
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895385
- Sponsor's protocol ID
- UP0034
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2019
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03895385
- Acronym / sponsor ID
- UP0034
- Conditions
- Healthy Volunteers
- Keywords
- BKZ, UCB4940, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab | Experimental | Drug: BimekizumabSubjects 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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimekizumabAlso: BKZ, UCB4940Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period. | Drug | Bimekizumab |
Primary outcome
Seroconversion response
Time frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)
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.
Plasma concentration of bimekizumab (BKZ)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Bimekizumab plasma concentrations by scheduled sampling time.
Incidence of Adverse Events (AE) from Baseline to Safety Follow Up
Time frame: From Baseline to Safety Follow Up (up to Day 140)
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.
8 secondary outcomes
Influenza antibody geometric mean titers (GMT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Maximum observed BKZ plasma drug concentration (Cmax)
Time frame: 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)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Apparent terminal half-life (t1/2)
Time frame: From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No. 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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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bimekizumab in people with Healthy Volunteers, run by UCB Biopharma S.P.R.L. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion response (time frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.