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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003199-36 | EudraCT Number |
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Study recruitment was terminated before the planned number of subjects was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.
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The study includes participants with moderate asthma who were randomly assigned to receive the study medication (CAT-354) or placebo.
This study is a randomized, double-blind, placebo controlled study. Following confirmation of eligibility, subjects with moderate asthma will be recruited sequentially to one of three dose groups and randomly assigned within dose group to either CAT-354 or placebo. Doses of the assigned treatment will be administered on three occasions 28 days apart. Follow up for pharmacokinetic blood sampling and safety will continue to Day 147 post-first dose (91 days post-third dose).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAT-354 1 mg/kg | Experimental | CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
| CAT-354 5 mg/kg | Experimental | CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
| CAT-354 10mg/kg | Experimental | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
| Placebo | Placebo Comparator | Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-354 1mg/kg | Biological | CAT-354 1 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | |
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35 | |
| Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147 | |
| Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 | |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
| Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half. | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
| Clearance (CL) for CAT-354 After First Dose |
| 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 first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MedImmune LLC | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiltern International Limited | Slough | Berkshire | SL1 2AD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20064211 | Background | Singh D, Kane B, Molfino NA, Faggioni R, Roskos L, Woodcock A. A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. BMC Pulm Med. 2010 Jan 8;10:3. doi: 10.1186/1471-2466-10-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CAT-354 1 mg/kg | CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| FG001 | CAT-354 5 mg/kg | CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| FG002 | CAT-354 10 mg/kg | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| FG003 | Placebo | Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received at least 1 dose of investigational medicinal product (IMP: CAT-354 or placebo) including those who did not complete the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CAT-354 1 mg/kg | CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| BG001 | CAT-354 5 mg/kg | CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| 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 | Maximum Observed Serum Concentration (Cmax) for CAT-354 After First Dose | Pharmacokinetic (PK) population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | microgram/milliliter (mcg/mL) | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
Day 0 to 147
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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 | 1 mg/kg | CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharospasm | Eye disorders | MedDRA 9.0 | Systematic Assessment |
Recruitment to the study was terminated before the planned number of participants was enrolled in CAT-354 10 mg/kg group due to the slow recruitment rate.
| 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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| CAT-354 5 mg/kg | Biological | CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
|
| CAT-354 10mg/kg | Biological | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
|
| Placebo | Other | Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant.
| Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
| Volume of Distribution (Vd) for CAT-354 After First Dose | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant. | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
| Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | Pre-dose on Day 28 |
| Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | Pre-dose on Day 56 |
| Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | Day 84 |
| Accumulation Ratio (R0) for CAT-354 | Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively. | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84 |
| Day 0 to Day 147 |
| Physician Decision |
|
| Participant on holiday; unable to attend |
|
| BG002 | CAT-354 10 mg/kg | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| BG003 | Placebo | Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | CAT-354 10 mg/kg | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. |
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Second Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 28; Day 35 |
|
|
|
| Primary | Maximum Observed Serum Concentration (Cmax) for CAT-354 After Third Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 56; Day 63, 84, 105 and 147 |
|
|
|
| Primary | Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0 - t]) for CAT-354 After First Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | (mcg*day)/mL | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
|
|
| Primary | Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0 - Infinity]) for CAT-354 After First Dose | AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity). | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | (mcg*day)/mL | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
|
|
| Primary | Apparent Terminal Elimination Phase Half-Life (t[1/2]el) for CAT-354 After First Dose | Terminal elimination phase half-life is the time measured for the serum concentration to decrease by one half. | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | days | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
|
|
| Primary | Clearance (CL) for CAT-354 After First Dose | Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Clearance was normalized by the body weight of the participant. | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | (mL/day)/kilogram | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
|
|
| Primary | Volume of Distribution (Vd) for CAT-354 After First Dose | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Volume of distribution was normalized to the body weight of the participant. | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. | Posted | Mean | Standard Deviation | mL/kg | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0; Day 4, 7, 14 and 21 |
|
|
|
| Primary | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After First Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose on Day 28 |
|
|
|
| Primary | Observed Serum Drug Concentration for CAT-354 28 Days (C28) After Second Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Pre-dose on Day 56 |
|
|
|
| Primary | Observed Serum Concentration for CAT-354 28 Days (C28) After Third Dose | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mcg/mL | Day 84 |
|
|
|
| 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 first dose of study drug and up to Day 147 that were absent before treatment or that worsened relative to pre-treatment state. | Safety population included all participants who received at least 1 dose of IMP (CAT-354 or placebo) including those who did not complete the study. | Posted | Number | participants | Day 0 to Day 147 |
|
|
|
| Primary | Accumulation Ratio (R0) for CAT-354 | Accumulation ratio is calculated as: R0 = AUC(56 - 84)/AUC(0 - 28) where AUC(0 - 28) and AUC(56 - 84) are the area under the serum concentration time curve over a dosage interval determined after the first dose (Day 0 to Day 28) and after the third dose (Day 56 to Day 84), respectively. | PK population included all participants in the safety population for whom sufficient post-dose blood samples were taken to estimate a Cmax. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | ratio | Pre-dose, 10 minutes and 12 hours post-end of infusion on Day 0 and 56; Pre-dose on Day 28; Day 4, 7, 14, 21, 63 and 84 |
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | 5 mg/kg | CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. | 1 | 8 | 8 | 8 |
| EG002 | 10 mg/kg | CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56. | 0 | 3 | 3 | 3 |
| EG003 | Placebo | Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56. | 0 | 4 | 4 | 4 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Feeling hot and cold | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 9.0 | 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 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 |
| TESAEs |
|