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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005503-33 | EudraCT Number |
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The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tralokinumab 300 mg | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | 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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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Piper, MBBS | MedImmune Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gliwice | Poland | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26182954 | Background | 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. |
| Label | URL |
|---|---|
| CD-RI-CAT-354-1054 Statistical Analysis Plan | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Reach Maximum Observed Serum Concentration (Tmax) | Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Median | Full Range | days | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 |
|
Day 1 to Day 57
Adverse events were summarized together for all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
Dose-normalized AUC(0-infinity) and dose-normalized Cmax were not evaluated as they were not relevant for single-dose study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meena Jain, MB BChir/Associate Medical Director | MedImmune, LLC | 301-398-0000 | jainm@medimmune.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C574065 | tralokinumab |
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|
| Day 1 to Day 57 |
| Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit | Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants. | Day 1 and Day 57 |
| Karpacz |
| Poland |
| Research Site | Lodz | Poland |
| CD-RI-CAT-354-1054 Redacted Protocol | View source |
Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) | PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Mean | Standard Deviation | microgram per milliliter (mcg/mL) | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 |
|
|
|
| Primary | 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). | PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Mean | Standard Deviation | (microgram*day)/milliliter (mcg*day/mL) | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 |
|
|
|
| Primary | Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) | PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Mean | Standard Deviation | mcg*day/mL | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 |
|
|
|
| Primary | 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. | PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Mean | Standard Deviation | days | 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 |
|
|
|
| Secondary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | 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. | Safety population included all participants who received investigational product. | Posted | Number | participants | Day 1 to Day 57 |
|
|
|
| Secondary | Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit | Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants. | PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration. | Posted | Number | participants | Day 1 and Day 57 |
|
|
|
| 0 |
| 20 |
| 6 |
| 20 |
| Injection site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |