Effect of IL--1β Inhibition on Inflammation and Cardiovas... | NCT02272946 | Trialant
NCT02272946
Sponsor
Priscilla Hsue, MD
Status
Completed
Last Update Posted
Apr 20, 2023Actual
Enrollment
43Actual
Phase
Phase 2
Conditions
HIV
Cardiovascular Disease
Interventions
Canakinumab
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02272946
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
Canakinumab
Secondary IDs
Not provided
Brief Title
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
Official Title
Effect of IL--1β Inhibition on Inflammation and Cardiovascular Risk
Acronym
Not provided
Organization
University of California, San FranciscoOTHER
Status Module
Record Verification Date
Mar 2023
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
Sep 2015
Primary Completion Date
Feb 2021Actual
Completion Date
Dec 2021Actual
First Submitted Date
Oct 13, 2014
First Submission Date that Met QC Criteria
Oct 21, 2014
First Posted Date
Oct 23, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 1, 2022
Results First Submitted that Met QC Criteria
Mar 29, 2023
Results First Posted Date
Apr 20, 2023Actual
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 29, 2023
Last Update Posted Date
Apr 20, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Priscilla Hsue, MD, Professor of Medicine, University of California, San FranciscoSponsor-Investigator
Lead Sponsor
Priscilla Hsue, MDOTHER
Collaborators
Name
Class
Massachusetts General Hospital
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to evaluate the effects of IL-1β inhibition on safety, measures of systemic and vascular inflammation and endothelial function (all indicators of cardiovascular risk) in treated and suppressed HIV infected individuals This study will assess the safety and effects of canakinumab on endothelial function (assessed by flow-mediated vasodilation [FMD] of the brachial artery), vascular inflammation (assessed by FDG-PET/CT scanning), key inflammatory markers of cardiovascular disease (CVD) risk (high-sensitivity C-reactive protein [hsCRP]), interleukin-6 (IL-6), soluble CD163 (sCD163), D-dimer, T-cell and monocyte activation in the blood, and size of the HIV reservoir. 10 individuals will receive a single dose of 150mg canakinumab with follow-up for 12 weeks. In the second part of the study, 100 participants will be randomized (2:1 - canakinumab to placebo) and will be followed by for 36 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
HIV
Cardiovascular Disease
Keywords
Not provided
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
43Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Safety Arm
Other
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Drug: Canakinumab
Canakinumab
Experimental
In Stage II: About 67 subjects will receive 150mg Canakinumab subcutaneous injection.
Drug: Canakinumab
Placebo
Placebo Comparator
In Stage II: About 33 subjects will receive 150mg placebo subcutaneous injection
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab
Drug
150mg Canakinumab received subcutaneously
Canakinumab
Safety Arm
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in CD4 Count From Baseline to Follow-up
Change in CD4 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in CD8 Count From Baseline to Follow-up
Change in CD8 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in Absolute Neutrophil Count From Baseline to Follow-up
Change in absolute neutrophil count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in Platelet Count From Baseline to Follow-up
Change in platelet count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in Creatinine Count From Baseline to Follow-up
Change in creatinine count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in AST From Baseline to Follow-up
Change in AST from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
weeks 4, 8, 12, 18, 24, and 36.
Change in ALT From Baseline to Follow-up
Change in ALT from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Secondary Outcomes
Measure
Description
Time Frame
Flow-Mediated Dilation (FMD)
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter
Baseline and Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
HIV infection,
Age ≥ 40 years < 60 years
On continuous ART for at least 12 months with no change in regimen in 12 weeks prior to study entry
CD4+ T cell count ≥ 400 cells/mm3
HIV RNA level below the standard limit of quantification for 52 weeks prior to entry
High risk for CAD as defined by either documented CVD (including prior MI) or diabetes mellitus or 1 CVD risk factor (current smoking, hypertension, dyslipidemia, or hsCRP≥2mg/L.)
Individuals on stable doses of lipid lowering therapy and/or anti-hypertensive medication will be allowed in the study.
Appropriate documentation from medical records of prior receipt of pneumococcal vaccinations
Exclusion Criteria:
Women of childbearing potential or pregnant/nursing women
CABG surgery in the past 3 years
Class IV heart failure
Uncontrolled HTN
History of tuberculosis or latent TB that is not treated
Nephrotic syndrome or eGFR< 30 ml/min/1.73m2
Active hepatic disease or active/chronic hepatitis B or C
Any prior malignancy including KS
Serious illness requiring hospitalization or active infection requiring antibiotics within 90 days
Requirement for live active vaccination 3 months prior to, during, and 3 months after study
Concurrent immune modulating therapy
Diabetes Mellitus
History of multiple imaging studies associated with radiation exposure
Neutropenia defined as ANC<1500/mm
Triglycerides>400 mg/dL
History of hypersensitivity to study drug
History of EBV-related lymphoproliferative disorders
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
FG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
FG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG00125 subjects
FG0028 subjects
COMPLETED
FG00010 subjects
FG00125 subjects
FG0028 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
The population are men or women who are at least 40 years, on stable anti-retroviral therapy and have documented cardiovascular disease or at risk for cardiovascular disease.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
BG001
Canakinumab
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
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
Change in CD4 Count From Baseline to Follow-up
Change in CD4 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log cells per mm^3
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
Adverse Events Module
Frequency Threshold
0
Time Frame
36 weeks
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
Safety Arm
In Stage 1: all 10 participants will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
Arterial Inflammation Measured at Baseline and Follow-up at Week 12
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT and reported as target-to-background (TBR) ratio to measure of vascular inflammation
Baseline (entry) and Week 12
D-Dimer
D-Dimer will be assessed from baseline to weeks 4, 8, 12, and 18.
Baseline, 4 weeks, 8 weeks, 12 weeks, and week 18
Human Serum Amyloid A (SAA)
SAA will be assessed from baseline to weeks 4, 12, and 18.
Baseline, 4 weeks, 12 weeks, and week 18
Tumor Necrosis Factor Alpha (TNFa)
TNFa will be assessed from baseline to weeks 4, 12, and 18.
Baseline, 4 weeks, 12 weeks, and week 18
The link above shows the current enrollment table of the Canakinumab study as of March 2, 2020.
IL-1B inhibition [by way of Canakinumab] Reduces Atherosclerotic Inflammation in HIV Infection - Journal of the American College of Cardiology
The link above is the research publication written by Dr. Hsue (Primary Investigator) about how IL-1B inhibition [by way of Canakinumab] reduces atherosclerotic inflammation in the setting of HIV.
In Stage II: 22 subjects will receive 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
BG002
Placebo
In Stage II: About 11 subjects will receive 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
BG003
Total
Total of all reporting groups
10
BG00125
BG0028
BG00343
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
Between 18 and 65 years
BG0009
BG00121
BG0027
BG00337
>=65 years
BG0001
BG0014
BG0021
BG0036
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0012
BG0020
BG0033
Male
BG0009
BG00123
BG0028
BG00340
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0021
BG0031
Not Hispanic or Latino
BG00010
BG00125
BG0027
BG00342
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
Asian
BG0000
BG0010
BG0021
BG0031
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0002
BG0015
BG0020
BG0037
White
BG0008
BG00120
BG0027
BG00335
More than one race
BG0000
BG0010
BG0020
BG0030
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
Hypertension
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0009
BG00110
BG0022
BG00321
Cardiovascular Disease
Cardiovascular is defined as prior myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention, or luminal stenosis of at least 50% in at least one coronary artery.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0003
BG0012
BG0021
BG0036
Diabetes
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0003
BG0012
BG0023
BG0038
Dyslipidemia on Statin Therapy
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
BG0008
BG00117
BG0024
BG00329
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG000-0.085(-0.170 to 0.008)
OG001-0.024(-0.106 to 0.065)
OG002-0.020(-0.149 to 0.129)
Week 8
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG000
Week 12
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG000
Week 18
ParticipantsOG0000
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG001
Week 24
ParticipantsOG0000
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG001
Week 36
ParticipantsOG0000
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
OG001
Primary
Change in CD8 Count From Baseline to Follow-up
Change in CD8 count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log cells per mm^3
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Primary
Change in Absolute Neutrophil Count From Baseline to Follow-up
Change in absolute neutrophil count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log unit (k) per uL
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Primary
Change in Platelet Count From Baseline to Follow-up
Change in platelet count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log unit (k) per uL
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Primary
Change in Creatinine Count From Baseline to Follow-up
Change in creatinine count from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log mg/dL
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Primary
Change in AST From Baseline to Follow-up
Change in AST from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log AST U/L
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Primary
Change in ALT From Baseline to Follow-up
Change in ALT from baseline (entry) to follow-up at weeks 4, 8, 12, 18, 24, and 36.
Safety only includes 10 individuals enrolled who received open label canakinumab and followed up to week 12.
Posted
Median
Inter-Quartile Range
log ALT U/L
weeks 4, 8, 12, 18, 24, and 36.
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 subjects will receive 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received 150mg placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Week 4
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Secondary
Flow-Mediated Dilation (FMD)
Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter
The safety arm is an open label study where brachial artery FMD was measured at baseline and week 8.
Posted
Mean
Inter-Quartile Range
Percent change in artery diameter
Baseline and Week 12
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received placebo subcutaneous injection
Placebo: 150mg Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Baseline FMD at 45 Seconds
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Secondary
Arterial Inflammation Measured at Baseline and Follow-up at Week 12
Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT and reported as target-to-background (TBR) ratio to measure of vascular inflammation
Posted
Mean
Standard Deviation
target-to-background ratio
Baseline (entry) and Week 12
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received placebo subcutaneous injection
Placebo: Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Baseline (Entry)
Title
Measurements
OG0003.27± 0.57
OG0013.18± 0.58
OG0023.85± 1.14
Week 12
Secondary
D-Dimer
D-Dimer will be assessed from baseline to weeks 4, 8, 12, and 18.
The safety arm is an open label study with D-Dimer markers evaluated at baseline, week 4, and week 8.
Posted
Median
Inter-Quartile Range
ng/mL
Baseline, 4 weeks, 8 weeks, 12 weeks, and week 18
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received placebo subcutaneous injection
Placebo: Placebo received subcutaneously
Units
Counts
Participants
OG00010
OG00125
OG0028
Title
Denominators
Categories
Baseline
ParticipantsOG00010
ParticipantsOG00125
ParticipantsOG0028
Title
Measurements
Secondary
Human Serum Amyloid A (SAA)
SAA will be assessed from baseline to weeks 4, 12, and 18.
The safety arm did not evaluate Human Serum Amyloid A
Posted
Median
Inter-Quartile Range
pg/mL
Baseline, 4 weeks, 12 weeks, and week 18
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received placebo subcutaneous injection
Placebo: Placebo received subcutaneously
Units
Counts
Participants
OG0000
OG00125
OG0028
Title
Denominators
Categories
Baseline
Title
Measurements
OG001479058.3(263456 to 44598329)
OG002513209.75(196985 to 842869.45)
Week 4
Title
Measurements
OG001
Secondary
Tumor Necrosis Factor Alpha (TNFa)
TNFa will be assessed from baseline to weeks 4, 12, and 18.
The safety arm did not evaluate Tumor Necrosis Factor Alpha
Posted
Median
Inter-Quartile Range
pg/mL
Baseline, 4 weeks, 12 weeks, and week 18
ID
Title
Description
OG000
Safety Arm
In Stage 1: all 10 participants received 150 mg Canakinumab subcutaneous injection. This will be a preliminary safety study (before Stage II).
Canakinumab: 150mg Canakinumab received subcutaneously
OG001
Canakinumab
In Stage II: 25 participants received150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
OG002
Placebo
In Stage II: 8 participants received placebo subcutaneous injection
Placebo: Placebo received subcutaneously
Units
Counts
Participants
OG0000
OG00125
OG0028
Title
Denominators
Categories
Baseline
Title
Measurements
OG0011.69(1.3 to 2.04)
OG0021.24(1.16 to 1.9)
Week 4
Title
Measurements
OG001
0
10
0
10
2
10
EG001
Canakinumab
In Stage II: 25 participants will receive 150mg Canakinumab subcutaneous injection.
Canakinumab: 150mg Canakinumab received subcutaneously
1
25
2
25
1
25
EG002
Placebo
In Stage II: 8 participants will receive 150mg placebo subcutaneous injection