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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04255862
Recruitment Status : Suspended (Study recruitment temporarily halted as a precautionary measure due to the COVID-19 pandemic)
First Posted : February 5, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

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.

Condition or disease Intervention/treatment Phase
Healthy Study Participants Drug: Bimekizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given as 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Test 1
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with bimekizumab-safety syringe-2 mL presentation (test 1).
Drug: Bimekizumab
Study participants will receive a single-dose of bimekzumab administered subcutaneously in the Treatment Period.
Other Names:
  • UCB4940
  • BKZ

Reference 1
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-safety syringe-1 mL presentation (reference 1).
Drug: Bimekizumab
Study participants will receive a single-dose of bimekzumab administered subcutaneously in the Treatment Period.
Other Names:
  • UCB4940
  • BKZ

Experimental: Test 2
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-2 mL presentation (test 2).
Drug: Bimekizumab
Study participants will receive a single-dose of bimekzumab administered subcutaneously in the Treatment Period.
Other Names:
  • UCB4940
  • BKZ

Reference 2
Study participants randomized to this arm will receive bimekizumab administered subcutaneously with a bimekizumab-auto-injector-1 mL (reference 2).
Drug: Bimekizumab
Study participants will receive a single-dose of bimekzumab administered subcutaneously in the Treatment Period.
Other Names:
  • UCB4940
  • BKZ




Primary Outcome Measures :
  1. Area under the curve (AUC) of a single dose bimekizumab (BKZ) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]
    AUC: Area under the plasma concentration-time curve from time 0 to infinity

  2. Area under the curve from time zero to t (AUC0-t) of a single dose bimekizumab (BKZ) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]
    AUC0-t: Area under the plasma concentration-time curve from time zero to time t

  3. Maximum plasma concentration (Cmax) of a single dose bimekizumab (BKZ) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]
    Cmax: Maximum observed plasma concentration


Secondary Outcome Measures :
  1. Percentage of participants with at least one treatment-emergent adverse event (TEAE) from Baseline to end of Safety Follow-Up [ Time Frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) ]
    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.

  2. Percentage of participants with at least one serious adverse event (SAE) from Baseline to end of Safety Follow-Up [ Time Frame: From Baseline (Day 1) to end of Safety Follow-Up (up to Day 140) ]

    A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalization or prolongation of existing hospitalization
    • Is a congenital anomaly or birth defect
    • Is an infection that requires treatment parenteral antibiotics
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

  3. Apparent terminal half-life (t1/2) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]
    Apparent terminal half-life, reported in units of days, as determined via simple linear regression (slope=-lambdaz) of natural log (ln) concentration versus time for data points in the terminal phase of the concentration-time curve. t1/2 is calculated as ln2/lambdaz.

  4. Time of occurrence of the maximum observed concentration (tmax) of a single dose bimekizumab (BKZ) [ Time Frame: From Baseline (Day 1 predose) at predefined time points (up to Day 140) ]
    tmax: time to reach maximum plasma concentration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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:

    1. Any active infection (except common cold) within 14 days prior to the Screening Visit
    2. A serious infection, defined as requiring hospitalization or iv anti-infectives within 2 months prior to the Screening Visit
    3. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04255862


Locations
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Germany
Up0068 001
Berlin, Germany
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04255862    
Other Study ID Numbers: UP0068
2019-002378-30 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
UCB4940
Bimekizumab
Bioequivalence
Auto-injector
Healthy study participants
Safety-syringe