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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
The purpose of the study is to evaluate the safety and tolerability of multiple-doses of tralokinumab in Japanese patients with Idiopathic Pulmonary Fibrosis.
This is a phase II, multicenter, blinded within cohort, dose-escalation study to evaluate the safety and tolerability of two ascending doses of tralokinumab in Japanese patients aged ≥ 50 years with mild to moderate Idiopathic Pulmonary Fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Investigational product Tralokinumab |
|
| High Dose | Experimental | Investigational product Tralokinumab |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tralokinumab cohort 1 | Biological | Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events | Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively. | From baseline to Week 48 (treatment-emergent only) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Tralokinumab Concentration Data | Serum tralokinumab concentration data will be summarized by treatment group. | From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48) |
| Immunogenecity |
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Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Confirmed IPF diagnosis for ≤ 5 years prior to Visit 1 (screening). Confirmation of diagnosis of IPF
Mild to moderate IPF to include all of the following at Visit 1
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph M Parker, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan | ||||
| Research Site |
20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo (tralokinumab low dose group: n=8, tralokinumab high dose group: n=8, placebo group: n=4).
A total of 37 patients were screened at 5 centres in Japan, and 20 patients were randomized and received at least 1 dose of tralokinumab low dose, high dose, or placebo.
The first patient entered the study on 24 January 2014 and the last patient last visit was on 19 November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks |
| FG001 | High Dose | Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks |
| FG002 | Placebo | Placebo Q4W intravenously dosed for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks |
| BG001 | High Dose | Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks |
| 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 | Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events | Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively. | Safety population | Posted | Number | Patients | From baseline to Week 48 (treatment-emergent only) |
|
From baseline to Week 48 (treatment-emergent only)
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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 | Low Dose | Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| tralokinumab cohort 2 | Biological | Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor |
|
| Placebo | Other |
|
The incidence rate of positive serum antibodies to tralokinumab will be reported. |
| From baseline to Week 48 |
| Himeji-shi |
| Japan |
| Research Site | Seto-shi | Japan |
| Research Site | Shibuya-ku | Japan |
| Research Site | Yokohama | Japan |
| BG002 | Placebo | Placebo Q4W intravenously dosed for 24 weeks |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| OG002 | Placebo | Placebo Q4W intravenously dosed for 24 weeks |
|
|
| Secondary | Serum Tralokinumab Concentration Data | Serum tralokinumab concentration data will be summarized by treatment group. | PK population | Posted | Mean | Standard Deviation | Microgram per milliliter | From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48) |
|
|
|
| Secondary | Immunogenecity | The incidence rate of positive serum antibodies to tralokinumab will be reported. | Safety population | Posted | Number | Patients | From baseline to Week 48 |
|
|
|
| 2 |
| 8 |
| 8 |
| 8 |
| EG001 | High Dose | Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks | 1 | 8 | 7 | 8 |
| EG002 | Placebo | Placebo Q4W intravenously dosed for 24 weeks | 1 | 4 | 2 | 4 |
| Bile duct stone | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 18.1 | Systematic Assessment |
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| Chronic gastritis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Noninfective gingivitis | Gastrointestinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 18.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 18.1 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA version 18.1 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 18.1 | Systematic Assessment |
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| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.1 | Systematic Assessment |
|
| Formication | Nervous system disorders | MedDRA version 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 18.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA version 18.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA version 18.1 | Systematic Assessment |
|
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| Week 12 (pre-dose) |
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| Week 28 |
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| Week 40 |
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| Week 48 |
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