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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Bimekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03895385

UP0034

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

56 participants in 2 patient groups

Bimekizumab

Experimental group

Description:

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.

Treatment:

Drug: Bimekizumab

No Treatment

No Intervention group

Description:

Subjects randomized to this arm will receive the influenza vaccine administered with a prefilled syringe at a predefined time point during the Treatment Period.