A Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection Using an Autoinjector in Healthy Study Participants

NCT05292131 | Completed Phase 1 Results FDA Drug

• 1 other identifier: UP0119
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants.

Conditions

Healthy Study Participants

Keywords

UCB4940; BKZ; bimekizumab; Bioequivalence; Auto-injector; Healthy study participants

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC) for a Single Dose Bimekizumab (BKZ)

  AUC is the area under the plasma concentration-time curve from time 0 (Day 1 predose) to infinity.

  Baseline (Day 1 predose) at predefined time points (up to Day 140)

• Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for a Single Dose Bimekizumab (BKZ)

  AUC0-t is the area under the plasma concentration-time curve from time zero (Day 1 predose) to the last quantifiable concentration.

  From Baseline (Day 1 predose) at predefined time points to the last quantifiable concentration (Day 140)

• Maximum Plasma Concentration (Cmax) for a Single Dose Bimekizumab (BKZ)

  Cmax is a maximum observed plasma concentration.

  From Baseline (Day 1 predose) at predefined time points (up to Day 140)

Secondary Outcomes (4)

• Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Baseline to End of Safety Follow-Up

  From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)

• Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) From Baseline to End of Safety Follow-Up

  From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140)

• Apparent Terminal Half-life (t1/2)

  From Baseline (Day 1 predose) at predefined time points (up to Day 140)

• Time of Occurrence of the Maximum Observed Concentration (Tmax) of a Single Dose Bimekizumab (BKZ)

  From Baseline (Day 1 predose) at predefined time points (up to Day 140)

Study Arms (2)

Test

EXPERIMENTAL

Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-2mL presentation (test).

Drug: bimekizumab

Reference

OTHER

Study participants randomized to this arm will receive bimekizumab (BKZ) administered subcutaneously with bimekizumab-AI-1x2mL presentation (reference).

Drug: bimekizumab

Interventions

bimekizumab DRUG

Study participants will receive a single dose of bimekizumab (BKZ) administered subcutaneously in the Treatment Period.

Also known as: BKZ; UCB4940

Reference; Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participant must be ≥18 years and ≤65 years of age inclusive, at the time of signing the informed consent
• Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests, during the Screening Period and on admission
• Study participant has a body temperature between 35.0°C and 37.5°C, inclusive, at Screening and on admission
• Body weight minimum of 50 kg for male and 45 kg for female study participants and a maximum of 100 kg for all study participants, and body mass index (BMI) within the range 18 to 32 kg/m\^2 (inclusive) at the Screening Visit
• Male or female. Contraception guidelines (as per the standard UCB contraceptive guideline) will be applicable.

You may not qualify if:

• Study participant has a known hypersensitivity to any components of the bimekizumab (and/or an investigational device) as stated in this protocol
• Study participant has an active infection or history of infections as follows:
• Any active infection (except common cold) within 14 days prior to Screening Visit
• A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
• A history of opportunistic, recurrent, or chronic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the study participant. Opportunistic infections are infections caused by uncommon pathogens (eg, pneumocystis jirovecii, cryptococcosis) or unusually severe infections caused by common pathogens (eg, cytomegalovirus, herpes zoster)
• Study participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to the Screening Visit (eg, inactivated influenza and pneumococcal vaccines are allowed, but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 20 weeks after the last dose of the investigational medicinal product (IMP)
• Study participant has previously participated in this study or a study participant has previously been assigned to bimekuzimab treatment in any other study
• Exposure to 3 or more new chemical entities within 12 months prior to dosing
• Current enrollment or past participation within the last 30 days before signing the informed consent form (ICF) in any other clinical study involving an investigational study intervention or any other type of medical research
• Study participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Study participants who have evidence of, or tested positive for hepatitis B or hepatitis C are excluded
• Study participant has made a blood donation of a blood loss of more than 400 mL of blood or blood products within 90 days prior to admission (Day -1) or plans to donate blood during the study
• Female study participant 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
• Study participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week (1 unit of alcohol is equivalent to 12.5 mL ethanol at room temperature)
• Study participant tests positive for alcohol or drugs (urine test) at Screening or Day -1
• Vulnerable study participants (eg, participants kept in detention, protected adults under guardianship or trusteeship, and soldiers or participants committed to an institution by governmental or juridical order), employees of the Sponsor or the contract research organization (CRO) with direct involvement in the proposed study or other studies under the direction of the Investigator or the CRO, as well as family members of the employees or the Investigator

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (2)

UP0119 2

Glendale, California, 91206, United States

Location

UP0119 1

Berlin, Germany

Location

MeSH Terms

Interventions

bimekizumab

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: March 17, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (1)