A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects

NCT03895385 | Completed Phase 1 FDA Drug

• 1 other identifier: UP0034
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

BKZ; UCB4940; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From Baseline to Safety Follow Up (up to Day 140)

Secondary Outcomes (8)

• Influenza antibody geometric mean titers (GMT)

  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)

  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)

  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)

  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)

  From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

Study Arms (2)

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.

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.

Interventions

Bimekizumab DRUG

Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.

Also known as: BKZ, UCB4940

Bimekizumab

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Up0034 001

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

bimekizumab

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: March 29, 2019
• Study Start: April 2, 2019
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)