NCT01592396

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

April 25, 2012

Results QC Date

October 3, 2016

Last Update Submit

January 20, 2017

Conditions

Asthma

Keywords

TralokinumabCAT-354Asthma

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

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

    Day 1 to Day 57

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

    Day 1 and Day 57

Study Arms (1)

Tralokinumab 300 mg

EXPERIMENTAL

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

Interventions

Tralokinumab 300 mgBIOLOGICAL

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.

Also known as: CAT-354
Tralokinumab 300 mg

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Gliwice, Poland

Location

Research Site

Karpacz, Poland

Location

Research Site

Lodz, Poland

Location

Related Publications (1)

  • Baverel PG, Jain M, Stelmach I, She D, Agoram B, Sandbach S, Piper E, Kuna P. Pharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing. Br J Clin Pharmacol. 2015 Dec;80(6):1337-49. doi: 10.1111/bcp.12725. Epub 2015 Oct 1.

    PMID: 26182954BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Interventions

tralokinumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Limitations and Caveats

Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study.

Results Point of Contact

Title
Meena Jain, MB BChir/Associate Medical Director
Organization
MedImmune, LLC
jainm@medimmune.com
301-398-0000

Study Officials

  • Edward Piper, MBBS

    MedImmune Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

May 7, 2012

Study Start

June 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 6, 2017

Results First Posted

January 20, 2017

Record last verified: 2017-01

Locations

PL(3)