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Business reasons
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
|
| MEDI-570 0.03 MG | Experimental | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
|
| MEDI-570 0.1 MG | Experimental | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
|
| MEDI-570 0.3 MG | Experimental | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
|
| MEDI-570 1 MG | Experimental | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 Day 169 that were absent before treatment or that worsened relative to pretreatment state. | Day 1 to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters for MEDI-570 | Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is 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; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Close, PhD | MedImmune Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Long Beach | California | United States | |||
| Research Site |
Due to premature termination of the study, planned treatment cohorts, MEDI-570, 3 milligram (mg) and MEDI-570, 10 mg, were not administered. A total of 17 participants were randomized in the study. An additional 27 participants were screened but not randomized in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
| FG001 | MEDI-570 0.03 MG | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MEDI-570 0.03 MG | Biological | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
|
| MEDI-570 0.1 MG | Biological | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
|
| MEDI-570 0.3 MG | Biological | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
|
| MEDI-570 1 MG | Biological | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
|
| Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169 |
| Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit | Predose on Day 1; Day 85, 113, and 169 |
| San Leandro |
| California |
| United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Ocala | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Lansing | Michigan | United States |
| Research Site | New York | New York | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Columbus | Ohio | United States |
| Research Site | London | Ontario | Canada |
| Research Site | Chihuahua City | Mexico |
| Research Site | Guadalajara | Mexico |
| Research Site | México | Mexico |
| Research Site | Lima | Peru |
| Research Site | Trujillo | Peru |
| Research Site | Cape Town | South Africa |
| Research Site | Johannesburg | South Africa |
| FG002 | MEDI-570 0.1 MG | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
| FG003 | MEDI-570 0.3 MG | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
| FG004 | MEDI-570 1 MG | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. |
| BG001 | MEDI-570 0.03 MG | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. |
| BG002 | MEDI-570 0.1 MG | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
| BG003 | MEDI-570 0.3 MG | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
| BG004 | MEDI-570 1 MG | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
| BG005 | 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 | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 Day 169 that were absent before treatment or that worsened relative to pretreatment state. | Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product. | Posted | Number | participants | Day 1 to Day 169 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameters for MEDI-570 | Following pharmacokinetic parameters were to be evaluated by using non-compartmental analysis: t1/2 = terminal phase elimination half-life which is the time measured for the serum concentration to decrease by one half; tmax = time to maximum observed serum concentration; Cmax = maximum observed serum concentration; AUC (0-t) = area under the serum concentration-time curve from time 0 to last measurable concentration; AUC (0-infinity) = area under the serum concentration-time curve from time 0 to extrapolated infinite time obtained from AUC (0-t) plus AUC (t-infinity); Vz/F = apparent volume of distribution, which is 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; CL/F = apparent clearance which is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. | Due to early termination of the study, the results were reported as individual participant's listings but not statistically summarized. | Posted | Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit | Safety population included all participants who were randomized into the study and received at least 1 dose of investigational product. | Posted | Number | participants | Predose on Day 1; Day 85, 113, and 169 |
|
Day 1 to Day 169
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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 | Placebo | A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1. | 0 | 3 | 3 | 3 | ||
| EG001 | MEDI-570 0.03 MG | A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1. | 0 | 1 | 1 | 1 | ||
| EG002 | MEDI-570 0.1 MG | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. | 1 | 1 | 1 | 1 | ||
| EG003 | MEDI-570 0.3 MG | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. | 2 | 7 | 7 | 7 | ||
| EG004 | MEDI-570 1 MG | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diastolic dysfunction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| General symptom | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Administration related reaction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Cd4 lymphocytes decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cutaneous lupus erythematosus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vasculitic rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
The study was terminated early by the sponsor due to business reasons.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Close, Director, Clinical Development | MedImmune, LLC. | 301-398-0000 | closeda@medimmune.com |
| 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 |
|---|---|
| C000627840 | MEDI-570 |
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| Male |
|
| TESAEs |
|
| OG002 | MEDI-570 0.1 MG | A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1. |
| OG003 | MEDI-570 0.3 MG | A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1. |
| OG004 | MEDI-570 1 MG | A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1. |
|
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
|
|