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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.
A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MEDI-546 100 mg IV |
|
| 2 | Experimental | MEDI-546 300 mg IV |
|
| 3 | Experimental | MEDI-546 1000 mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDI-546 | Drug | Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Summary of Adverse Events | Stage I (up to 48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax | Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29 | |
| Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast | Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberta Weiss, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chiba | 260-8677 | Japan | |||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | MEDI-546 100 mg IV | Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| FG001 | MEDI-546 300 mg IV | Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| FG002 | MEDI-546 1000 mg IV | Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage I |
|
| ||||||||||||||||||
| Stage II |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MEDI-546 100 mg IV | Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| BG001 | MEDI-546 300 mg IV |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax | Posted | Geometric Mean | Geometric Coefficient of Variation | ug/mL | Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29 |
|
Stage I: 337 to 422 days
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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-546 100 mg IV | Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nsopharyngitis | Infections and infestations | MedDRA version 19.1 | Non-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 |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582345 | anifrolumab |
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| MEDI-546 | Drug | Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks |
|
| MEDI-546 | Drug | Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV. |
|
| Anti-drug Antibody (ADA) | MEDI-546 antibody detection measured by electrochemiluminescence (ECL). | Stage I (up to Week 48) |
| Chūōku |
| 104-8560 |
| Japan |
| Research Site | Ōta-ku | 143-8541 | Japan |
| Research Site | Sendai | 980-8574 | Japan |
| Research Site | Shimotsuke-shi | 329-0498 | Japan |
| Research Site | Shinjuku-ku | 160-8582 | Japan |
| NOT COMPLETED |
|
|
Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
| BG002 | MEDI-546 1000 mg IV | Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | male/female |
|
| MEDI-546 1000 mg IV |
Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV |
|
|
| Primary | Overall Summary of Adverse Events | Posted | Count of Participants | Participants | Stage I (up to 48 weeks) |
|
|
|
| Secondary | Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast | Posted | Geometric Mean | Geometric Coefficient of Variation | ug.day/mL | Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29 |
|
|
|
| Secondary | Anti-drug Antibody (ADA) | MEDI-546 antibody detection measured by electrochemiluminescence (ECL). | Posted | Count of Participants | Participants | Stage I (up to Week 48) |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | MEDI-546 300 mg IV | Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks | 0 | 5 | 2 | 5 | 5 | 5 |
| EG002 | MEDI-546 1000 mg IV | Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV | 0 | 6 | 3 | 6 | 6 | 6 |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA version 19.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 19.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Any AE with outcome=death |
|
| Any SAE |
|
| Any AE leading to discontinuation of IP |
|
| Any causally related AE |
|
| Any other significant AE |
|
| Title | Measurements |
|---|---|
|