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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 1

Locations

Poland

Study Type

Interventional

Intervention

Tralokinumab 300 mg

About this trial

This is an interventional treatment trial for Asthma focused on measuring Tralokinumab, CAT-354, Asthma

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tralokinumab 300 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to Reach Maximum Observed Serum Concentration (Tmax)

Maximum Observed Serum Concentration (Cmax)

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).

Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01592396

First Posted

April 25, 2012

Last Updated

January 20, 2017

Sponsor

MedImmune LLC

1. Study Identification

Unique Protocol Identification Number

NCT01592396

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedImmune LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Tralokinumab, CAT-354, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tralokinumab 300 mg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Tralokinumab 300 mg

Other Intervention Name(s)

CAT-354

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to Reach Maximum Observed Serum Concentration (Tmax)

Time Frame