A Study to Compare the Blood Level of Bimekizumab Injecte... | NCT03707717

ID	Type	Description	Link
2017-004403-48	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bimekizumab-SS	Experimental	Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a prefilled syringe.	Drug: Bimekizumab
Bimekizumab-AI	Experimental	Subjects randomized to this arm will receive bimekizumab administered subcutaneously with an auto-injector.	Drug: Bimekizumab
Bimekizumab-TN	Experimental	Subjects randomized to this arm will receive bimekizumab administered subcutaneously with a reference device.	Drug: Bimekizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimekizumab	Drug	Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.	Bimekizumab-AI Bimekizumab-SS Bimekizumab-TN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed bimekizumab (BKZ) plasma drug concentration (Cmax)	The Cmax is the maximum plasma drug concentration of BKZ observed from pharmacokinetic samples taken at predefined time points.	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 last quantifiable concentration (AUCt)	The AUCt is the area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUCt) of BKZ as determined using the linear trapezoidal rule.	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)	The area under the plasma concentration-time curve from time zero to infinity (AUC) of BKZ is calculated as AUC=AUCt+Clast/lambdaz, where Clast is the last quantifiable plasma concentration and λz is the apparent terminal elimination rate constant.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)
Percentage of subjects with at least one Adverse Event (AE) from first bimekizumab (BKZ) dose up 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)
Percentage of subjects with at least one Serious Adverse Event (SAE) from first bimekizumab (BKZ) dose up to Safety Follow Up

Secondary Outcomes

Measure	Description	Time Frame
Percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (%AUCex)	The percentage of the AUC extrapolated from the last quantifiable BKZ plasma concentration (Clast) is computed from plasma concentrations of pharmacokinetic samples taken at predefined time points.	From Baseline (Day 1 pre-dose) at predefined time points (up to Day 140)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is male or female aged >=18 years and <=55 years at Screening Visit
Participant must be in good health (physically and mentally) as determined by the Investigator based on medical history (any chronic and acute illness), physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory screening tests during the Screening Period
Participant has a body mass index (BMI) of 18-32 kg/m2 and a minimum body weight of 50 kg for male participants and 45 kg for female participants, and a maximum body weight of 100 kg for all participants
Participant is willing to abstain from alcohol-, tobacco-, and caffeine-containing products for 48 h prior to admission into the clinic and during the entire in-clinic stay

Exclusion Criteria:

Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
Participant has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening Visit
Participant has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Female 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
Participants receiving any live (includes attenuated) vaccination within the 8 weeks prior to 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 IMP
Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
Participant has active neoplastic disease or history of neoplastic disease within 5 years of 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)

Name	Affiliation	Role
UCB Cares	001 844 599 2273 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Up0033 002		Baltimore	Maryland	21225	United States
Up0033 001

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 as 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