Trial Outcomes & Findings for A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma (NCT NCT01592396)
NCT ID: NCT01592396
Last Updated: 2017-03-06
Results Overview
COMPLETED
PHASE1
30 participants
0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57
2017-03-06
Participant Flow
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.
Participant milestones
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
Baseline characteristics by cohort
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.6 Years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
15.8 Years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
14.2 Years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57Population: Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax)
|
5.2 days
Full Range (3.0-9.1) • Interval 3.0 to 9.1
|
6.1 days
Full Range 2.9-9.0 • Interval 2.9 to 9.0
|
PRIMARY outcome
Timeframe: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57Population: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
|
57.0 microgram per milliliter (mcg/mL)
Standard Deviation 21.7
|
50.6 microgram per milliliter (mcg/mL)
Standard Deviation 16.2
|
PRIMARY outcome
Timeframe: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57Population: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
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).
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])
|
1916.0 (microgram*day)/milliliter (mcg*day/mL)
Standard Deviation 806.3
|
1721.1 (microgram*day)/milliliter (mcg*day/mL)
Standard Deviation 568.5
|
PRIMARY outcome
Timeframe: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57Population: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])
|
1561.4 mcg*day/mL
Standard Deviation 614.9
|
1384.6 mcg*day/mL
Standard Deviation 421.6
|
PRIMARY outcome
Timeframe: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57Population: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=10 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
n=10 Participants
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2)
|
21.4 days
Standard Deviation 5.5
|
22.1 days
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 57Population: Safety population included all participants who received investigational product.
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.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=20 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
6 participants
|
—
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 57Population: PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.
Outcome measures
| Measure |
Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1
n=20 Participants
Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
|
Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
|
|---|---|---|
|
Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit
|
0 participants
|
—
|
Adverse Events
Tralokinumab 300 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tralokinumab 300 mg
n=20 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
|
General disorders
Injection site pruritus
|
5.0%
1/20 • Number of events 1 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
3/20 • Number of events 4 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Number of events 1 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • Day 1 to Day 57
Adverse events were summarized together for all participants.
|
Additional Information
Meena Jain, MB BChir/Associate Medical Director
MedImmune, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER