A Study to Evaluate the Bioequivalence of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants

NCT04255862 | Terminated Phase 1 Results

• 2 other identifiers: UP00682019-002378-30
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1x2 mL versus 2x1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants.

Conditions

Healthy Study Participants

Keywords

UCB4940; Bimekizumab; Bioequivalence; Auto-injector; Healthy study participants; Safety-syringe

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 bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to infinity.

  From 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 bimekizumab plasma concentration-time curve from time zero (Day 1 predose) to the last observed 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 the 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 (4)

Test 1

EXPERIMENTAL

Study participants randomized to this arm will receive bimekizumab administered subcutaneously with bimekizumab-safety syringe-2 mL presentation (test 1).

Drug: Bimekizumab

Reference 1

OTHER

Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-safety syringe-1 mL presentation (reference 1).

Drug: Bimekizumab

Test 2

EXPERIMENTAL

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

Drug: Bimekizumab

Reference 2

OTHER

Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-1 mL (reference 2).

Drug: Bimekizumab

Interventions

Bimekizumab DRUG

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

Also known as: UCB4940, BKZ

Reference 1; Reference 2; Test 1; Test 2

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 Visit 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

You may not qualify if:

• Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
• Study participant has a known hypersensitivity to any excipients of bimekizumab (and/or an investigational device) as stated in this protocol
• Study participant has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, peripheral arterial disease sufficient to cause symptoms, and/or requires therapy to maintain stable status
• Study participant has an active infection or history of infections as follows:
• Any active infection (except common cold) within 14 days prior to the 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 participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at the Screening Visit
• 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 12-lead ECG with changes considered to be clinically significant (eg, QT interval corrected using Fridericia's formula \[QTcF\] \>450 ms, bundle branch block, or evidence of myocardial ischemia) at the Screening Visit or on Day -1
• Study participant has active neoplastic disease or history of neoplastic disease within 5 years of the Screening Visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
• 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 dose of the investigational medicinal product (IMP)
• Study participant has previously participated in this study or the study participant has previously been assigned to treatment in a study of the medication under investigation in this study
• Study participant has participated in another study of an IMP (and/or an investigational device) within the previous 90 days or 5 half-lives, whichever is longer, prior to IMP administration
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0068 001

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 (UCB)

  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: February 3, 2020
• First Posted: February 5, 2020
• Study Start: February 12, 2020
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)