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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDI-545 1.0 mg/kg | Experimental | Cohort 1 |
|
| MEDI-545 3.0 mg/kg | Experimental | Cohort 2 |
|
| MEDI-545 10.0 mg/kg | Experimental | Cohort 3 |
|
| MEDI-545 100 mg | Experimental | Cohort 4 |
|
| MEDI-545 600 mg | Experimental | Cohort 5 |
|
| MEDI-545 1,200 mg | Experimental | Cohort 6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-545 | Drug | Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Each Category of Adverse Events in Stage I | Stage I (up to 1 year) | |
| Number of Participants in Each Category of Adverse Events (AE) in Stage II | Stage II (1 year to 3.5 years after first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | After first dose in Stage I (0 upto 28 days) | |
| AUC0-14 of MEDI-545 After First Dose in Stage I | Summary of area under the concentration-time curve from zero to Day 14. |
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Inclusion Criteria:
Exclusion Criteria:
Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)
Have received the following medications within 28 days before Visit 2 (Day 1):
Women who have a positive pregnancy test (serum hCG) at Visit 1
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| Name | Affiliation | Role |
|---|---|---|
| Tsutomu Takeuchi | Department of Internal Medicine School of Medicine Keio University | Principal Investigator |
| Yoshiya Tanaka | The University Hospital, University of Occupational and Environmental Health, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chiba | 260-8712 | Japan | |||
| Research Site |
Thirty (30) patients received MEDI-545 either IV or SC treatment (5 patients in each cohort) at Stage I. Twenty-six (26) patients completed Stage I treatment and, out of these 26 patients, 21 patients were registered to continue in Stage II.
This study was conducted at 7 centres in Japan. The first patient was enrolled on 25 November 2009 and the last enrolled patient had completed Stage II on 11 July 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | MEDI-545 1.0 mg/kg IV | MEDI-545 1.0 mg/kg IV once every 2 weeks |
| FG001 | MEDI-545 3.0 mg/kg IV | MEDI-545 3.0 mg/kg IV once every 2 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage I |
|
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| MEDI-545 | Drug | Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses |
|
| MEDI-545 | Drug | Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses. |
|
| MEDI-545 | Drug | Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses. Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses. |
|
| MEDI-545 | Drug | Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses |
|
| MEDI-545 600 | Drug | Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses. Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses. |
|
| After first dose in Stage I |
| Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | After first dose in Stage I |
| Change From Baseline in 21-gene Signature Fold Change in Stage I | 21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene. | Stage I |
| Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | Stage I |
| Fukuoka |
| 810-8563 |
| Japan |
| Research Site | Kanazawa | 920-8650 | Japan |
| Research Site | Kawagoe-shi | 350-8550 | Japan |
| Research Site | Kitakyushu-shi | 807-8555 | Japan |
| Research Site | Sapporo | 060-8638 | Japan |
| Research Site | Shinjuku-ku | 160-8582 | Japan |
| FG002 | MEDI-545 10.0 mg/kg IV | MEDI-545 10.0 mg/kg IV once every 2 weeks |
| FG003 | MEDI-545 100 mg SC | MEDI-545 100 mg SC once every 2 weeks |
| FG004 | MEDI-545 600 mg IV | MEDI-545 600 mg IV once every 4 weeks |
| FG005 | MEDI-545 1200 mg IV | MEDI-545 1200 mg IV once every 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| Stage II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MEDI-545 1.0 mg/kg IV | MEDI-545 1.0 mg/kg IV once every 2 weeks |
| BG001 | MEDI-545 3.0 mg/kg IV | MEDI-545 3.0 mg/kg IV once every 2 weeks |
| BG002 | MEDI-545 10.0 mg/kg IV | MEDI-545 10.0 mg/kg IV once every 2 weeks |
| BG003 | MEDI-545 100 mg SC | MEDI-545 100 mg SC once every 2 weeks |
| BG004 | MEDI-545 600 mg IV | MEDI-545 600 mg IV once every 4 weeks |
| BG005 | MEDI-545 1200 mg IV | MEDI-545 1200 mg IV once every 4 weeks |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I | Pharmacokinetics (PK) populaton | Posted | Median | Full Range | day*ug/mL | After first dose in Stage I (0 upto 28 days) |
|
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| |||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-14 of MEDI-545 After First Dose in Stage I | Summary of area under the concentration-time curve from zero to Day 14. | PK populaton | Posted | Geometric Mean | Geometric Coefficient of Variation | day*ug/mL | After first dose in Stage I |
| ||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Each Category of Adverse Events in Stage I | Safety population | Posted | Count of Participants | Participants | Stage I (up to 1 year) |
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I | PK populaton | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | After first dose in Stage I |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 21-gene Signature Fold Change in Stage I | 21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene. | Safety population | Posted | Mean | Standard Deviation | fold change | Stage I |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I | Safety population | Posted | Count of Participants | Participants | Stage I |
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants in Each Category of Adverse Events (AE) in Stage II | Safety population | Posted | Count of Participants | Participants | Stage II (1 year to 3.5 years after first dose) |
|
Upto 1 year after treatment start for Stage I, 1 year to 3.5 years after treatment start for Stage II
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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 | MEDI-545 1.0 mg/kg IV | MEDI-545 1.0 mg/kg IV once every 2 weeks | 0 | 5 | 0 | 5 | 5 | 5 |
| EG001 | MEDI-545 3.0 mg/kg IV | MEDI-545 3.0 mg/kg IV once every 2 weeks | 0 | 5 | 3 | 5 | 4 | 5 |
| EG002 | MEDI-545 10.0 mg/kg IV | MEDI-545 10.0 mg/kg IV once every 2 weeks | 0 | 5 | 3 | 5 | 5 | 5 |
| EG003 | MEDI-545 100 mg SC | MEDI-545 100 mg SC once every 2 weeks | 0 | 5 | 4 | 5 | 5 | 5 |
| EG004 | MEDI-545 600 mg IV | MEDI-545 600 mg IV once every 4 weeks | 0 | 5 | 2 | 5 | 5 | 5 |
| EG005 | MEDI-545 1200 mg IV | MEDI-545 1200 mg IV once every 4 weeks | 0 | 5 | 5 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Cataract | Eye disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Auditory disorders | Ear and labyrinth disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Bronchitis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Pneumonia | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Pyelonephritis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Sepsis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Acute myocardial infarction | Cardiac disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Prinzmetal angina | Cardiac disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Cataract | Eye disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Budd-Chiari syndrome | Hepatobiliary disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Cerebral infaraction | Nervous system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Deep vein thrombosis | Vascular disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Otitis media | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Dental caries | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
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| Nausea | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
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| Headache | Nervous system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
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| Fatigue | General disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage I |
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| Pyrexia | General disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Nasopharyngitis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Gastroenteritis | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Influenza | Infections and infestations | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Gastritis | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Nausea | Gastrointestinal disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Headache | Nervous system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Dizziness | Nervous system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 19.0 | Non-systematic Assessment | Study Period: Stage II |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C568334 | sifalimumab |
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| Other |
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| Male |
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| OG005 |
| MEDI-545 1200mg IV |
MEDI-545 1200mg IV once every 4 weeks |
|
|
MEDI-545 1200mg IV once every 4 weeks |
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|
MEDI-545 1200mg IV once every 4 weeks |
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| OG005 | MEDI-545 1200mg IV | MEDI-545 1200mg IV once every 4 weeks |
|
|
MEDI-545 1200mg IV once every 4 weeks |
|
|
MEDI-545 1200mg IV once every 4 weeks |
|
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