Study Evaluating The Safety And Tolerability Of ILV-094 I... | NCT00563524 | Trialant
NCT00563524
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Aug 23, 2024Actual
Enrollment
76Actual
Phase
Phase 1
Conditions
Psoriasis
Interventions
ILV-094
Countries
United States
Canada
Hong Kong
South Africa
Protocol Section
Identification Module
NCT ID
NCT00563524
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3199K2-1105
Secondary IDs
ID
Type
Description
Link
B1981002
Other Identifier
Alias Study Number
2009-012554-20
EudraCT Number
Brief Title
Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis
Official Title
AN ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY OR INTRAVENOUSLY TO SUBJECTS WITH PSORIASIS
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2024
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 20, 2007Actual
Primary Completion Date
Jun 14, 2010Actual
Completion Date
Jun 14, 2010Actual
First Submitted Date
Nov 21, 2007
First Submission Date that Met QC Criteria
Nov 23, 2007
First Posted Date
Nov 26, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 23, 2022
Results First Submitted that Met QC Criteria
Apr 2, 2024
Results First Posted Date
Aug 23, 2024Actual
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
Apr 2, 2024
Last Update Posted Date
Aug 23, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
76Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Placebo Comparator
Drug: ILV-094
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ILV-094
Drug
SC and IV administration on days 1, 14, 28, and 42
1
placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug to the end of study (Day 126), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both SAEs and all non-SAEs.
Day 1 up to Day 126
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Clinically significant ECG findings included: heart rate (HR): less than or equal to (<=) 45 beats per minute (bpm) or greater than or equal to (>=)120 bpm or decrease/increase of >=15 bpm from baseline value, PR interval: >=220 millisecond (msec) and change of >=20 msec from baseline value and; QRS interval >=120 msec; corrected QT (QTc) interval for men greater than (>) 450 msec, QTc interval for women >470 msec.
Day 1 up to Day 126
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
Criteria for identifying vital sign values of PCI: heart rate: increase of >15 bpm from baseline value and >=120 bpm and decrease of >15 bpm from baseline value and <=45 bpm; Sitting and Supine systolic blood pressure (SBP): increase of >=20 millimeters of mercury (mm Hg) from baseline value and >=160 mm Hg and decrease of >=20 mm Hg from baseline value and <=90 mm Hg; Sitting and Supine diastolic blood pressure (DBP): increase of >=15 mm Hg from baseline value and >=100 mm Hg and decrease of >=15 mm Hg from baseline value and <=50 mm Hg; Respiratory rate: <10 or >25 breaths/minute; Weight: >=7 percent increase or decrease from baseline value; Oral temperature: <35 degree Celsius (C) or >38.3 degree C.
Day 1 up to Day 126
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Positive Anti-Drug Antibodies Response
Participants with their ADA titer levels >=6.23 were considered to be ADA positive. Participants with at least 1 positive ADA titer are reported.
Day 1 up to Day 126
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and Women of nonchildbearing potential 18 years or older.
Physician Area and Severity Index (PASI) greater than 11.
Physician Global Assessment (PGA) greater than 3.
Exclusion Criteria:
Use of any investigational small -molecule drug within 30 days before the first dose of test article administration, and use of any investigational biologic agents within 5 half lives before study day 1, or 90 days for investigational biologics that may have a long clinical duration of effect.
Live vaccines within 3 months before test article administration or during the study.
Use of any biologic therapy within approximately 5 half-lives before test article administration. Approximate half-lives of biologic therapies approved for psoriasis are as follows: Enbrel, 5 days; Humira, 14 days; Remicade, 9 days; Amevive, 12 days; Raptiva, 6 days. It is recommended that Amevive be discontinued for at least 90 days because of its long clinical duration of action.
Psoralen plus ultraviolet A radiation (PUVA) therapy within 4 weeks before study day 1.
Ultraviolet B (UVB) therapy within 2 weeks before study day 1.
Receipt of systemic psoriasis therapy (eg, oral retinoids, methotrexate, hydroxyurea, cyclosporine, or azathioprine) or systemic corticosteroids within 4 weeks before study day 1.
Topical steroids, topical vitamin A or D analog preparations, or anthralin within 2 weeks before study day 1. (Exception: topical therapies, including steroids at no higher than mild strength [class 6 or 7 topical corticosteroids], are permitted on the scalp, axillae, face, and groin, but the dose of the medication must be kept stable throughout the trial.)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
David Stoll, MD
Beverly Hills
California
90212
United States
Dermatology Research
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Criteria:Hematocrit:5% decrease from baseline,Hemoglobin:decrease of >=20 gram per liter(g/L) from baseline,WBC: <3.0*10^9/L;neutrophils: <1.5*10^9/L,platelet count:<100*10^9/L,eosinophils: >0.5*10^9/L;prothrombin time,partial thromboplastin time: >1.5*Upper limit of normal(ULN);sodium,potassium: >5millimoles per liter(mmol/L)aboveULN/below lower limit of normal(LLN),creatinine: >1.36*ULN,urea: >1.5*ULN,glucose(fasting): >0.83mmol/L above ULN/below ULN,glucose (non-fasting): >5.0 mmol/L above ULN/>0.56 mmol/L below LLN,calcium:change of >=0.25 mmol/L from baseline,magnesium:change at >=0.21mmol/L from baseline value,phosphorus:>0.162 mmol/L above ULN/below LLN,total protein:change of >=20 g/L from baseline,albumin:change of >=10 g/L from baseline,uric acid:change of >0.119mmol/L from baseline,creatine kinase: >3*ULN,cholesterol: >7.77mmol/L,triglycerides:>3.39mmol/L;ALT,AST,total bilirubin: >2*ULN,alkaline phosphatase: >1.5*ULN,Gamma-glutamyl transferase,lactate dehydrogenase: >3*ULN.
Day 1 up to Day 126
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Terminal Half-Life (t1/2) of ILV-094: Single Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
AUC (0-312) = Area under the plasma concentration time-curve from time zero (pre-dose) to 312 hours (0-312) postdose of ILV-094.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after IV dose (apparent clearance) was influenced by the fraction of the dose absorbed.
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Apparent Volume of Distribution of ILV-094: Multiple Dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Cavg was the average plasma concentration of drug during the dosing interval.
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Accumulation Ratio (Rac) of ILV-094
Rac was estimated as: X*AUClast of Day 1 divided by AUC312 of Day 42, where X is the ratio of the maintenance dose to the loading dose of ILV-094, AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration and AUC-312 is the AUC from time 0 to 312 hours on Day 42.
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation.
Day 1, 14, 28, 42, 56
Serum Interleukin-6 (IL-6) Levels
Day 1, 14, 28, 42, 56
Serum Amyloid-A Levels
Day 1, 14, 28, 42, 56
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
PASI score is the combined assessment of lesion severity and area affected into single score range on a scale of 0 (no disease) to 72 (maximal disease), with higher scores indicating greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
TLS was based on the severity of 3 components: erythema, induration, and scaling. Severity of each component was evaluated on a 5-point scale as: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with higher scores reflected increased lesion severity. Scores of 3 components were summed to derive the total target lesion score, ranging from 0=none to 12=very marked, with higher scores reflected increased lesion severity.
Baseline, Week 2, 4, 6, 8, 12
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 = no disease activity to 10 = extreme disease activity, where higher scores indicating greater disease activity.
Baseline, Week 2, 4, 6, 8, 12
Santa Monica
California
90404
United States
Miami Research Associates
South Miami
Florida
33143
United States
MRA Clinical Research
South Miami
Florida
33143
United States
Hudson Dermatology
Evansville
Indiana
47714
United States
Dawes Fretzin Clinical Research Group
Indianapolis
Indiana
46256
United States
Dawes Fretzin Dermatology Group
Indianapolis
Indiana
46256
United States
Hamzavi Dermatology
Fort Gratiot
Michigan
48059
United States
Central Dermatology
St Louis
Missouri
63117
United States
New York University Medical Center
New York
New York
10016
United States
Mount Sinai School of Medicine
New York
New York
10029
United States
Duke Clinical Reseach Unit
Durham
North Carolina
27710
United States
The Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635-0909
United States
Baylor Research Institute
Dallas
Texas
75246-1613
United States
Stratical Medical
Edmonton
Alberta
T5K 1X3
Canada
University of Alberta, Hospital Site Clinical Sciences Building
Edmonton
Alberta
T6G 2B7
Canada
The Northern Alberta Clinical Trials and Research Centre (NACTRC)
Edmonton
Alberta
T6G 2C8
Canada
Bio Pharma Services Inc
Toronto
Ontario
M9L 3A2
Canada
K. Papp Clinical Research
Waterloo
Ontario
N2J 1C4
Canada
Innovaderm Recherches Inc
Montreal
Quebec
H2K 4L5
Canada
Queen Mary Hospital
Hong Kong
Hong Kong
FARMOVS Parexel (Pty) Ltd
Bloemfontein
Free State
9301
South Africa
Parexel George
George
Western Cape
6529
South Africa
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
FG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
FG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
FG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
FG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
FG00013 subjects
FG00112 subjects
FG00213 subjects
FG00312 subjects
FG00413 subjects
FG00513 subjects
COMPLETED
FG00011 subjects
FG0019 subjects
FG00210 subjects
FG00312 subjects
FG00411 subjects
FG00512 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Safety analysis population included all randomized participants who received at least 1 dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
BG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
BG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
BG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
BG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
BG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00013
BG00112
BG00213
BG00312
BG00413
BG00513
BG00676
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
BG00038.54± 12.73
BG00145.92± 10.15
BG00244.46± 14.66
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
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 (AEs) And Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent were events between first dose of study drug to the end of study (Day 126), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both SAEs and all non-SAEs.
Safety analysis population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Day 1 up to Day 126
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0003
OG0019
OG0027
OG003
Primary
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Clinically significant ECG findings included: heart rate (HR): less than or equal to (<=) 45 beats per minute (bpm) or greater than or equal to (>=)120 bpm or decrease/increase of >=15 bpm from baseline value, PR interval: >=220 millisecond (msec) and change of >=20 msec from baseline value and; QRS interval >=120 msec; corrected QT (QTc) interval for men greater than (>) 450 msec, QTc interval for women >470 msec.
Safety analysis population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Day 1 up to Day 126
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Primary
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
Criteria for identifying vital sign values of PCI: heart rate: increase of >15 bpm from baseline value and >=120 bpm and decrease of >15 bpm from baseline value and <=45 bpm; Sitting and Supine systolic blood pressure (SBP): increase of >=20 millimeters of mercury (mm Hg) from baseline value and >=160 mm Hg and decrease of >=20 mm Hg from baseline value and <=90 mm Hg; Sitting and Supine diastolic blood pressure (DBP): increase of >=15 mm Hg from baseline value and >=100 mm Hg and decrease of >=15 mm Hg from baseline value and <=50 mm Hg; Respiratory rate: <10 or >25 breaths/minute; Weight: >=7 percent increase or decrease from baseline value; Oral temperature: <35 degree Celsius (C) or >38.3 degree C.
Safety analysis population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Day 1 up to Day 126
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Primary
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Criteria:Hematocrit:5% decrease from baseline,Hemoglobin:decrease of >=20 gram per liter(g/L) from baseline,WBC: <3.0*10^9/L;neutrophils: <1.5*10^9/L,platelet count:<100*10^9/L,eosinophils: >0.5*10^9/L;prothrombin time,partial thromboplastin time: >1.5*Upper limit of normal(ULN);sodium,potassium: >5millimoles per liter(mmol/L)aboveULN/below lower limit of normal(LLN),creatinine: >1.36*ULN,urea: >1.5*ULN,glucose(fasting): >0.83mmol/L above ULN/below ULN,glucose (non-fasting): >5.0 mmol/L above ULN/>0.56 mmol/L below LLN,calcium:change of >=0.25 mmol/L from baseline,magnesium:change at >=0.21mmol/L from baseline value,phosphorus:>0.162 mmol/L above ULN/below LLN,total protein:change of >=20 g/L from baseline,albumin:change of >=10 g/L from baseline,uric acid:change of >0.119mmol/L from baseline,creatine kinase: >3*ULN,cholesterol: >7.77mmol/L,triglycerides:>3.39mmol/L;ALT,AST,total bilirubin: >2*ULN,alkaline phosphatase: >1.5*ULN,Gamma-glutamyl transferase,lactate dehydrogenase: >3*ULN.
Safety analysis population included all randomized participants who received at least 1 dose of study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Day 1 up to Day 126
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Pharmacokinetic (PK) analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.
Posted
Geometric Mean
Standard Deviation
Microgram per milliliter
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
Secondary
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
Microgram per milliliter
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.
Posted
Median
Full Range
Hour
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 600 mg + 300 mg Intravenous
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Median
Full Range
Hour
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
One per day
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
The terminal-phase disposition rate constant measured by a log-linear regression of the terminal mono exponential portion of the observed plasma concentrations, expressed in 1/day.
PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
One per day
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Terminal Half-Life (t1/2) of ILV-094: Single Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Days
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Days
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters.
Posted
Geometric Mean
Standard Deviation
Hour*microgram per milliliter
Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
AUC (0-312) = Area under the plasma concentration time-curve from time zero (pre-dose) to 312 hours (0-312) postdose of ILV-094.
PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Apparent Clearance of ILV-094: Multiple Dose
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after IV dose (apparent clearance) was influenced by the fraction of the dose absorbed.
PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
Milliliter per hour
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Secondary
Apparent Volume of Distribution of ILV-094: Multiple Dose
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
PK analysis set. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
Milliliter
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Cavg was the average plasma concentration of drug during the dosing interval.
PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Standard Deviation
Microgram per milliliter
Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Accumulation Ratio (Rac) of ILV-094
Rac was estimated as: X*AUClast of Day 1 divided by AUC312 of Day 42, where X is the ratio of the maintenance dose to the loading dose of ILV-094, AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration and AUC-312 is the AUC from time 0 to 312 hours on Day 42.
PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Serum C-Reactive Protein (CRP) Levels
CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation.
Pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Posted
Mean
Standard Deviation
Milligram per deciliter
Day 1, 14, 28, 42, 56
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Serum Interleukin-6 (IL-6) Levels
PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 1, 14, 28, 42, 56
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Secondary
Serum Amyloid-A Levels
PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.
Posted
Mean
Standard Deviation
Picogram per milliliter
Day 1, 14, 28, 42, 56
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Secondary
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
PASI score is the combined assessment of lesion severity and area affected into single score range on a scale of 0 (no disease) to 72 (maximal disease), with higher scores indicating greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).
PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD and clinical disease evaluations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Data were not collected at week 12 with subcutaneous administration.
Posted
Mean
Standard Deviation
Percent change
Baseline, Week 2, 4, 6, 8, 12
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
Secondary
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
TLS was based on the severity of 3 components: erythema, induration, and scaling. Severity of each component was evaluated on a 5-point scale as: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked, with higher scores reflected increased lesion severity. Scores of 3 components were summed to derive the total target lesion score, ranging from 0=none to 12=very marked, with higher scores reflected increased lesion severity.
PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD and clinical disease evaluations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Data were not collected at week 12 with subcutaneous administration.
Posted
Mean
Standard Deviation
Percent change
Baseline, Week 2, 4, 6, 8, 12
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Secondary
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 = no disease activity to 10 = extreme disease activity, where higher scores indicating greater disease activity.
PD analysis population included all randomized participants who received at least 1 dose of study medication and had all available PD and clinical disease evaluations. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. Data were not collected at week 12 with subcutaneous administration.
Posted
Mean
Standard Deviation
Percent change
Baseline, Week 2, 4, 6, 8, 12
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Other Pre-specified
Number of Participants With Positive Anti-Drug Antibodies Response
Participants with their ADA titer levels >=6.23 were considered to be ADA positive. Participants with at least 1 positive ADA titer are reported.
Safety analysis population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Day 1 up to Day 126
ID
Title
Description
OG000
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 milligram (mg) on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
Time Frame
Not provided
Description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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
ILV-094 100 mg + 50 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 100 mg on Day 1 and then 50 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
0
13
3
13
EG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
0
12
9
12
EG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
0
13
7
13
EG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
0
12
11
12
EG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
2
13
9
13
EG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
0
13
9
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG0030 affected12 at risk
EG0041 affected13 at risk
EG0050 affected13 at risk
Chest pain
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG0030 affected12 at risk
EG0040 affected13 at risk
EG0050 affected13 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Cataract
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Eye discharge
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Eyelid irritation
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Vision blurred
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Asthenia
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Chest discomfort
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Fatigue
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Influenza like illness
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pain
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0002 affected13 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Viral infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Arthroscopy
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0021 affected13 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0001 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Blood glucose increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Heart rate increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Lymph node palpable
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Urinary sediment present
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0013 affected12 at risk
EG0020 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Migraine
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0012 affected12 at risk
EG0020 affected13 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0022 affected13 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Bromhidrosis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0011 affected12 at risk
EG0020 affected13 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Erythrodermic psoriasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0021 affected13 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected13 at risk
EG0010 affected12 at risk
EG0020 affected13 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000629141
fezakinumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0051 subjects
48.42
± 14.02
BG00447.69± 8.49
BG00542.00± 15.55
BG00644.43± 12.89
2
BG0032
BG0042
BG0052
BG0069
Male
BG00013
BG00111
BG00211
BG00310
BG00411
BG00511
BG00667
12
OG00413
OG00513
11
OG0049
OG0059
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0050
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0022
OG0033
OG0044
OG0053
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0023
OG0032
OG0045
OG0054
OG001
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00312
OG00413
OG00513
Title
Denominators
Categories
Title
Measurements
OG00010
OG00110
OG0027
OG00310
OG0047
OG0057
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00313
Title
Denominators
Categories
Title
Measurements
OG0006.292± 6.719
OG00120.151± 32.716
OG00279.475± 30.964
OG003167.916± 32.488
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG0007.096± 5.138
OG00119.222± 29.002
OG00263.133± 21.736
OG003113.523± 39.872
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00313
Title
Denominators
Categories
Title
Measurements
OG000152.50(48.0 to 263.9)
OG001107.77(48.5 to 310.3)
OG0024.00(1.0 to 314.1)
OG0033.00(1.0 to 4.0)
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG00048.07(8.0 to 215.6)
OG001119.94(47.2 to 263.8)
OG0022.00(1.0 to 4.0)
OG0033.00(0.0 to 24.0)
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData could not be calculated because values were below lower limit of quantification.
OG001NA± NAData could not be calculated because values were below lower limit of quantification.
OG0020.06623± 0.01438
OG0030.08079± 0.01501
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00310
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData could not be calculated because values were below lower limit of quantification.
OG001NA± NAData could not be calculated because values were below lower limit of quantification.
OG0020.04554± 0.00793
OG0030.05302± 0.01163
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG0028
OG00312
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData could not be calculated because values were below lower limit of quantification.
OG001NA± NAData could not be calculated because values were below lower limit of quantification.
OG00210.64± 1.99
OG0038.69± 1.42
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00310
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData could not be calculated because values were below lower limit of quantification.
OG001NA± NAData could not be calculated because values were below lower limit of quantification.
OG00215.43± 2.68
OG00313.45± 3.62
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00313
Title
Denominators
Categories
Title
Measurements
OG0001333± 1490
OG0014212± 7783
OG0028880± 2554
OG00321358± 3696
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG0001532± 734
OG0014241± 6434
OG0029474± 3412
OG00318352± 4810
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG00030.944± 20.160
OG00122.536± 11.687
OG00215.092± 4.832
OG00315.586± 5.410
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00212
OG00310
Title
Denominators
Categories
Title
Measurements
OG000NA± NAData could not be calculated because values were below lower limit of quantification.
OG001NA± NAData could not be calculated because values were below lower limit of quantification.
OG0027953± 1996
OG0037174± 2283
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG0004.809± 2.316
OG00113.206± 20.301
OG00229.580± 10.792
OG00357.287± 14.946
OG002
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00011
OG00110
OG00212
OG00311
Title
Denominators
Categories
Title
Measurements
OG0002.739± 0.852
OG0012.147± 1.283
OG0022.134± 0.854
OG0031.684± 0.375
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Day 1
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00311
ParticipantsOG00411
ParticipantsOG00513
Title
Measurements
OG0000.700± 1.075
OG0011.943± 3.837
OG0020.939± 2.017
OG003
Day 14
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Day 28
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00311
Day 42
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00311
Day 56
ParticipantsOG0008
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00311
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG003
OG004
Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.5237
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.8463
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.4596
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.6345
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.6235
Superiority or Other (legacy)
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG00510
Title
Measurements
OG0003.14± 3.46
OG00113.05± 22.01
OG0024.93± 6.07
OG003
Day 14
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00310
Day 28
ParticipantsOG0007
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG0039
Day 42
ParticipantsOG0006
ParticipantsOG00110
ParticipantsOG0028
ParticipantsOG0038
Day 56
ParticipantsOG0006
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG0037
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG003
OG004
Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.3833
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.4909
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.2200
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.4183
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.4650
Superiority or Other (legacy)
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Day 1
ParticipantsOG00013
ParticipantsOG00111
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00411
ParticipantsOG00512
Title
Measurements
OG00026586201± 39787546
OG00133048188± 45868899
OG00222784245± 47173620
OG003
Day 14
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Day 28
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00312
Day 42
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00312
Day 56
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00312
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG003
OG004
Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.7051
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.1072
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.0020
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.0079
Superiority or Other (legacy)
OG000
OG001
OG003
OG004
Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.
ANCOVA
0.0308
Superiority or Other (legacy)
ILV-094 200 mg + 100 mg Subcutaneous
Participants received ILV-094 subcutaneous injections at a loading dose of 200 mg on Day 1 and then 100 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Week 2
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00513
Title
Measurements
OG00013.1± 17.3
OG00113.5± 18.1
OG0022.57± 9.29
OG003
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 6
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
OG002
Placebo Subcutaneous
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Week 2
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00513
Title
Measurements
OG0001.38± 1.76
OG0010.75± 1.21
OG0021.00± 1.60
OG003
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 6
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Participants received placebo matched to ILV-094 subcutaneous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
OG003
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.
Units
Counts
Participants
OG00013
OG00112
OG00213
OG00312
OG00413
OG00513
Title
Denominators
Categories
Week 2
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
ParticipantsOG00413
ParticipantsOG00513
Title
Measurements
OG0000.46± 0.78
OG0010.33± 0.49
OG0020.17± 0.39
OG003
Week 4
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 6
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 8
ParticipantsOG00013
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00312
Week 12
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
ILV-094 300 mg + 150 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 300 mg on Day 1 and then 150 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG004
ILV-094 600 mg + 300 mg Intravenous
Participants received ILV-094 intravenous injections at a loading dose of 600 mg on Day 1 and then 300 mg maintenance dose on Day 14, 28 and 42. Participants were followed up to 18 weeks.
OG005
Placebo Intravenous
Participants received placebo matched to ILV-094 intravenous injections on Day 1, 14, 28 and 42. Participants were followed up to 18 weeks.