A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects
Part of paid clinical trials in San Antonio, Texas.
- Sponsor
- UCB Biopharma S.P.R.L.
- Study ID
- NCT03895385
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Bimekizumab — DRUGSubjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
Study Details
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.
Key Dates
- Start date
- Apr 2, 2019
- Status verified
- Sep 2020
- Primary completion
- Oct 4, 2019
- Completion
- Oct 4, 2019
Study Design
- Enrollment
- 56 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: 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 Intervention: No TreatmentSubjects randomized to this arm will receive the influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period.
Primary Outcome Measure
Seroconversion response [ Time Frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Up0034 001 | San Antonio | Texas | 78209 | - |
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