Clinical Trial Results:
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents with Asthma
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Summary
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EudraCT number |
2011-005503-33 |
Trial protocol |
PL |
Global end of trial date |
09 Jan 2013
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Results information
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Results version number |
v1 |
This version publication date |
02 May 2016
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First version publication date |
05 Aug 2015
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CD-RI-CAT-354-1054
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01592396 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
MedImmune, LLC
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Sponsor organisation address |
Milstein Building, Grant Park, Cambridge, United Kingdom, CB21 6GH
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Public contact |
Meena Jain, MB BChir/Associate Medical Director, MedImmune, LLC, jainm@medimmune.com
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Scientific contact |
Meena Jain, MB BChir/Associate Medical Director, MedImmune, LLC, jainm@medimmune.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000782-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Jan 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jan 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective was to evaluate the pharmacokinetic (PK) profile of a single 300 milligram (mg) of subcutaneous (SC) dose of tralokinumab in adolescent subjects with asthma.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
20
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Twenty (20) participants enrolled and completed the study as planned. An additional 10 participants signed informed consent but were not enrolled in the study. The reasons for screen failures were not meeting the inclusion/exclusion criteria, and/or consent withdrawal. | |||||||||
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Pre-assignment
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Screening details |
Screening Details: A total of 20 participants participated in the study at 3 investigative sites in Poland. | |||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1 | |||||||||
Arm description |
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tralokinumab
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Investigational medicinal product code |
CAT-354
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
300 mg and Subcutaneous use
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Arm title
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Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2 | |||||||||
Arm description |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Tralokinumab
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Investigational medicinal product code |
CAT-354
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
300 mg and Subcutaneous use
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Baseline characteristics reporting groups
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Reporting group title |
Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
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Reporting group description |
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
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Reporting group description |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
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Subject analysis set title |
Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
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Subject analysis set type |
Sub-group analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set 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.
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Subject analysis set title |
Tralokinumab 300 mg
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set 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.
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End points reporting groups
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Reporting group title |
Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
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Reporting group description |
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1. | ||
Reporting group title |
Tralokinumab 300 mg (Participants aged 15-17 years) - Cohort 2
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Reporting group description |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1. | ||
Subject analysis set title |
Tralokinumab 300mg (Participants aged 15-17 years) - Cohort 2
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
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Subject analysis set title |
Tralokinumab 300 mg (Participants aged 12-14 years) - Cohort 1
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set 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.
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Subject analysis set title |
Tralokinumab 300 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set 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.
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End point title |
Time to Reach Maximum Observed Serum Concentration (Tmax) [1] [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical data was not planned to be reported for this endpoint. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Statistical data was not planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Maximum Observed Serum Concentration (Cmax) [3] [4] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical data was not planned to be reported for this endpoint. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Statistical data was not planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) [5] [6] | ||||||||||||
End point 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).
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End point type |
Primary
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End point timeframe |
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical data was not planned to be reported for this endpoint. [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Statistical data was not planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) [7] [8] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical data was not planned to be reported for this endpoint. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Statistical data was not planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Terminal Phase Elimination Half Life (t1/2) [9] [10] | ||||||||||||
End point description |
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
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End point type |
Primary
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End point timeframe |
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical data was not planned to be reported for this endpoint. [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Statistical data was not planned to be reported for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | ||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 57
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at any Visit | ||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Day 1 and Day 57
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to Day 57
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Adverse event reporting additional description |
Adverse events were summarized together for all participants.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
Tralokinumab 300 mg
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Reporting 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study. Apparent volume of distribution at steady state (Vss/F) was replaced by Vz/F as it was more relevant for subcutaneous dose. | |||
