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

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ClinicalTrials.gov Identifier: NCT01592396
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : January 20, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Biological: Tralokinumab 300 mg
Enrollment 30
Recruitment Details A total of 30 participants were screened, out of which 20 were randomized into the study. The reasons for screen failures were not meeting the inclusion/exclusion criteria, and/or consent withdrawal.
Pre-assignment Details  
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2 Total
Hide Arm/Group Description Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
12.6  (0.7) 15.8  (0.9) 14.2  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
3
  30.0%
6
  30.0%
Male
7
  70.0%
7
  70.0%
14
  70.0%
1.Primary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description:
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Overall Number of Participants Analyzed 10 10
Median (Full Range)
Unit of Measure: days
5.2
(3.0 to 9.1)
6.1
(2.9 to 9.0)
2.Primary Outcome
Title Maximum Observed Serum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description:
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter (mcg/mL)
57.0  (21.7) 50.6  (16.2)
3.Primary Outcome
Title Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
Hide Description 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).
Time Frame 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description:
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: (microgram*day)/milliliter (mcg*day/mL)
1916.0  (806.3) 1721.1  (568.5)
4.Primary Outcome
Title Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
Hide Description [Not Specified]
Time Frame 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description:
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mcg*day/mL
1561.4  (614.9) 1384.6  (421.6)
5.Primary Outcome
Title Terminal Phase Elimination Half Life (t1/2)
Hide Description Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Time Frame 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1 Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Hide Arm/Group Description:
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: days
21.4  (5.5) 22.1  (3.5)
6.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description 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.
Time Frame Day 1 to Day 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received investigational product.
Arm/Group Title Tralokinumab 300 mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
TEAEs 6
TESAEs 0
7.Secondary Outcome
Title Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
Hide Description Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.
Time Frame Day 1 and Day 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Arm/Group Title Tralokinumab 300mg
Hide Arm/Group 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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
0
Time Frame Day 1 to Day 57
Adverse Event Reporting Description Adverse events were summarized together for all participants.
 
Arm/Group Title Tralokinumab 300 mg
Hide Arm/Group 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.
All-Cause Mortality
Tralokinumab 300 mg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tralokinumab 300 mg
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tralokinumab 300 mg
Affected / at Risk (%) # Events
Total   6/20 (30.00%)    
Gastrointestinal disorders   
Diarrhoea  1  1/20 (5.00%)  1
General disorders   
Injection site pruritus  1  1/20 (5.00%)  1
Infections and infestations   
Nasopharyngitis  1  3/20 (15.00%)  4
Pharyngitis  1  1/20 (5.00%)  1
Nervous system disorders   
Headache  1  2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
Urticaria  1  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The Principal Investigator (PIs) also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: Meena Jain, MB BChir/Associate Medical Director
Organization: MedImmune, LLC
Phone: 301-398-0000
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 )
First Submitted: April 25, 2012
First Posted: May 7, 2012
Results First Submitted: October 3, 2016
Results First Posted: January 20, 2017
Last Update Posted: March 6, 2017