A Trial to Investigate the Pharmacokinetics of Tralokinumab in Adolescents, a Product Under Investigation for the Treatment of Asthma (CAT354-1054)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01592396
First received: April 25, 2012
Last updated: May 22, 2013
Last verified: May 2013

April 25, 2012
May 22, 2013
July 2012
January 2013   (final data collection date for primary outcome measure)
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation (AUC(0-infinity); AUC(0-t)); dose-normalized AUC(0-infinity) (AUC(0-infinity)/D);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation Cmax; dose-normalized Cmax (Cmax/D); time to Cmax (Tmax);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation dose-normalized terminal-phase elimination half-life (t1/2);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation apparent clearance (CL/F)
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation steady-state volume of distribution (Vss/F).
Same as current
Complete list of historical versions of study NCT01592396 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    To evaluate the saftey and tolerability of tralokinumab through monitoring of adverse event data from day 1 - day 57.
  • Safety and Tolerability through the measure of Immunogenicity [ Time Frame: Day 1 - Day 57 ] [ Designated as safety issue: Yes ]
    To evaluate the saftey and tolerability of tralokinumab through collection of immunogenicity samples to be tested for anti-drug antibodies
Same as current
Not Provided
Not Provided
 
A Trial to Investigate the Pharmacokinetics of Tralokinumab in Adolescents, a Product Under Investigation for the Treatment of Asthma
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

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

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 IgE synthesis and mast cell activation.Tralokinumab (CAT‐354) is a human 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 pharmacokinetic 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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Asthma
Biological: Cohort 1
Tralokinumab (CAT‐354) is a human IgG4 anti‐IL‐13 monoclonal antibody that has been shown to potently and specifically neutralize IL‐13 in preclinical models.
Cohort 1
Active
Intervention: Biological: Cohort 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 12-17 years (inclusive)
  • Weight > 30kg
  • Asthma for a minimum of 6 months
  • 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 < 3 months
  • Known immune deficiency
  • History of cancer
  • Hepatitis B, C or HIV
  • Any disease which may cause complications whilst taking the study drug
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01592396
CD-RI-CAT-354-1054, 2011-005503-33
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Edward Piper, MBBS MedImmune Ltd
MedImmune LLC
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP