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NCT Number: NCT01592396

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Gliwice, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tralokinumab 300 mg

Biological

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.

Other names: CAT-354

Primary outcomes

  1. Time to Reach Maximum Observed Serum Concentration (Tmax)

    Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57

  2. Maximum Observed Serum Concentration (Cmax)

    Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57

  3. Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])

    Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57

    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).

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

    Time frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57

  5. Terminal Phase Elimination Half Life (t1/2)

    Time frame: 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 is the time measured for the serum concentration to decrease by one half.

Secondary outcomes

  1. Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 to Day 57

    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.

  2. Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit

    Time frame: Day 1 and Day 57

    Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 7, 2012
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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