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 — DRUG
    Subjects 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

First listed
Mar 29, 2019
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: 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.
  • 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.

Primary Outcome Measure

Seroconversion response [ Time Frame: From Baseline (Day 1 pre-dose) to 4 weeks post-vaccination (Day 43) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Up0034 001San AntonioTexas78209-

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Up0034 001· San Antonio, TX

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