A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

Study Overview
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Brief Summary
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The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Detailed Description
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Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.

Official Title
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A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: Tralokinumab 300 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-17 years (inclusive) Weight greater than (>) 30 kilogram (kg) Asthma for a minimum of 6 months prior to Screening Effective birth control for both male and female participants in line with protocol details. Exclusion Criteria: Previously taken tralokinumab (the study drug) Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals Pregnant or breastfeeding women Current smoker or cessation less than (<) 3 months prior to screening Known immune deficiency excluding asymptomatic selective immunoglobulin A History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive Any disease which may cause complications whilst taking the study drug.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tralokinumab 300 mg<br>Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. | Biological: Tralokinumab 300 mg<br>* Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.<br>* Other names: CAT-354;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Reach Maximum Observed Serum Concentration (Tmax) |  | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 | 
| Maximum Observed Serum Concentration (Cmax) |  | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 | 
| Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 | 
| Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) |  | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 | 
| Terminal Phase Elimination Half Life (t1/2) | Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half. | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants. | Day 1 to Day 57 | 
| Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit | Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants. | Day 1 and Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tralokinumab, CAT-354, Asthma