This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01592396
First received: April 25, 2012
Last updated: January 20, 2017
Last verified: January 2017
  Purpose
The pharmacokinetic (PK) profile of tralokinumab (CAT‐354) will be studied in adolescent subjects with asthma.

Condition Intervention Phase
Asthma Biological: Tralokinumab 300 mg Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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).

  • 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 ]
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 30
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tralokinumab 300 mg
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
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 Name: CAT-354

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.
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592396

Locations
Poland
Research Site
Gliwice, Poland
Research Site
Karpacz, Poland
Research Site
Łódź, Poland
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Edward Piper, MBBS MedImmune Ltd
  More Information

Additional Information:
Publications:
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01592396     History of Changes
Other Study ID Numbers: CD-RI-CAT-354-1054
2011-005503-33 ( EudraCT Number )
Study First Received: April 25, 2012
Results First Received: October 3, 2016
Last Updated: January 20, 2017

Keywords provided by MedImmune LLC:
Tralokinumab
CAT-354
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017