A Study to Evaluate the Safety, Pharmacokinetics, and Pha... | NCT03351738 | Trialant
NCT03351738
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Mar 23, 2020Actual
Enrollment
133Actual
Phase
Phase 2
Conditions
Stable Coronary Heart Disease
Interventions
MEDI5884
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03351738
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D7870C00002
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
Official Title
A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Subjects With Stable Coronary Heart Disease
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 13, 2017Actual
Primary Completion Date
Nov 9, 2018Actual
Completion Date
Nov 9, 2018Actual
First Submitted Date
Oct 12, 2017
First Submission Date that Met QC Criteria
Nov 21, 2017
First Posted Date
Nov 24, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Nov 8, 2019
Results First Submitted that Met QC Criteria
Dec 4, 2019
Results First Posted Date
Dec 19, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 10, 2020
Last Update Posted Date
Mar 23, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.
Detailed Description
A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.
Conditions Module
Conditions
Stable Coronary Heart Disease
Keywords
Coronary heart disease
Pharmacokinetic
Pharmacodynamics
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
133Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Drug: Placebo
MEDI5884 50 mg
Experimental
Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
Drug: MEDI5884
MEDI5884 100 mg
Experimental
Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
Drug: MEDI5884
MEDI5884 200 mg
Experimental
Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
Drug: MEDI5884
MEDI5884 350 mg
Experimental
Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
Drug: MEDI5884
MEDI5884 500 mg
Experimental
Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI5884
Drug
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
MEDI5884 100 mg
MEDI5884 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Apolipoprotein B
Change from baseline in apolipoprotein B is reported.
Day 1 (Baseline), and Days 31, 61, and 91
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of stable coronary heart disease prior to screening
Currently receiving high intensity statin(s)
Exclusion Criteria:
Unstable cardiovascular conditions
Any planned arterial revascularizations
Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
A total of 248 participants consented to participate in the study, of which 115 were screen failures. A total of 133 participants were randomized to the study of which only 132 received treatment. One participant was ineligible, being randomized by error but not followed or treated.
Recruitment Details
The study was conducted in the US between 13Dec2017 and 09Nov2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
FG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Placebo
Day 1 (Baseline) through Day 241
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
Day 1 (Baseline) through Day 241
Percent change from baseline in HDL-C is reported.
Day 1 (Baseline), and Days 31, 61, and 91
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
AUC30d after the last dose of MEDI5884 is reported.
Day 61 (pre-dose), and on Days 64, 68, 71, and 91
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
FG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
FG004
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
FG005
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
FG00023 subjects
FG00120 subjects
FG00224 subjects
FG00322 subjects
FG00421 subjects
FG00522 subjects
COMPLETED
FG00023 subjects
FG00119 subjects
FG00224 subjects
FG00321 subjects
FG00421 subjects
FG00522 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
BG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
BG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
BG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
BG004
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
BG005
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG00120
BG00224
BG00322
BG00421
BG00522
BG006132
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.3± 8.4
BG00163.8± 8.4
BG00267.4± 5.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
As-treated population: All participants who received any dose of study drug and analyzed according to actual treatment they received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated anti-drug antibodies (ADA), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) levels at Day 151 visit.
Posted
Count of Participants
Participants
Day 1 (Baseline) through Day 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
OG004
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
OG005
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
Units
Counts
Participants
OG00023
OG00120
OG00224
OG003
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00017
OG00110
OG00211
OG003
Primary
Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline
Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Posted
Count of Participants
Participants
Day 1 (Baseline) through Day 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
Primary
Number of Participants With Clinically Important Changes in Vital Signs From Baseline
Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Posted
Count of Participants
Participants
Day 1 (Baseline) through Day 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
Primary
Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline
Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Posted
Count of Participants
Participants
Day 1 (Baseline) through Day 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG003
Primary
Number of Participants With Clinically Important Changes in Physical Examinations From Baseline
Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.
Posted
Count of Participants
Participants
Day 1 (Baseline) through Day 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
Secondary
Change From Baseline in Apolipoprotein B
Change from baseline in apolipoprotein B is reported.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.
Posted
Mean
Standard Deviation
mg/dL
Day 1 (Baseline), and Days 31, 61, and 91
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
Secondary
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
Percent change from baseline in HDL-C is reported.
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, "number analyzed" signifies number of participants analyzed for the specified time point.
Posted
Mean
Standard Deviation
Percent change
Day 1 (Baseline), and Days 31, 61, and 91
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
Secondary
Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884
AUC30d after the last dose of MEDI5884 is reported.
Pharmacokinetic (PK) evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
Posted
Mean
Standard Deviation
μg⋅day/mL
Day 61 (pre-dose), and on Days 64, 68, 71, and 91
ID
Title
Description
OG000
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG001
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG002
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
OG003
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
OG004
Secondary
Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose
Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.
The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
Posted
Mean
Standard Deviation
μg/mL
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
ID
Title
Description
OG000
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG001
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG002
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
OG003
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
OG004
Secondary
Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose
Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.
The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.
Posted
Mean
Standard Deviation
Days
Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151
ID
Title
Description
OG000
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG001
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG002
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
OG003
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
Secondary
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884
Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).
As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.
Posted
Count of Participants
Participants
Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241
ID
Title
Description
OG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
OG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
OG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
OG003
MEDI5884 200 mg
Time Frame
Day 1 through Day 241
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
0
23
2
23
9
23
EG001
MEDI5884 50 mg
Participants received SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
0
20
2
20
9
20
EG002
MEDI5884 100 mg
Participants received SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
0
24
1
24
6
24
EG003
MEDI5884 200 mg
Participants received SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
0
22
0
22
12
22
EG004
MEDI5884 350 mg
Participants received SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
0
21
4
21
13
21
EG005
MEDI5884 500 mg
Participants received SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
0
22
0
22
13
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected22 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected22 at risk
Angina unstable
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected22 at risk
EG0040 events0 affected21 at risk
EG0051 events1 affected22 at risk
Angina unstable
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Vitreous adhesions
Eye disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Influenza like illness
General disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Injection site bruising
General disorders
MedDRA 21
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Injection site erythema
General disorders
MedDRA 21
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Injection site swelling
General disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Oedema peripheral
General disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Furuncle
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Apolipoprotein b increased
Investigations
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected24 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Crystal urine present
Investigations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Liver function test increased
Investigations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0002 events2 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Syncope
Nervous system disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Calculus bladder
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Urine flow decreased
Renal and urinary disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Allergic cough
Respiratory, thoracic and mediastinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 21
Systematic Assessment
EG0000 events0 affected23 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Hypotension
Vascular disorders
MedDRA 21
Systematic Assessment
EG0001 events1 affected23 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected24 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises on going 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.