Psoriasis
Conditions
Brief summary
The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis
Interventions
DRUGILV-094
SC and IV administration on days 1, 14, 28, and 42
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Day 1 up to Day 126 | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | Day 1 up to Day 126 | 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. |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Day 1 up to Day 126 | 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. |
| Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | Day 1 up to Day 126 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1 | 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. |
| Terminal-phase Disposition Rate Constant 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 | 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. |
| Terminal Half-Life (t1/2) 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 | Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. |
| Terminal Half-Life (t1/2) 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 | Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) 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 | AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. |
| Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose | Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-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. |
| Apparent Clearance 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 | 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. |
| Average Observed Plasma Concentration (Cavg) 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 | Cavg was the average plasma concentration of drug during the dosing interval. |
| Accumulation Ratio (Rac) of ILV-094 | Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose | 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. |
| Serum C-Reactive Protein (CRP) Levels | Day 1, 14, 28, 42, 56 | 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. |
| 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 | Baseline, Week 2, 4, 6, 8, 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). |
| Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Baseline, Week 2, 4, 6, 8, 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. |
| Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Baseline, Week 2, 4, 6, 8, 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. |
| Apparent Volume of Distribution 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 | 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. |
| 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 | — |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Anti-Drug Antibodies Response | Day 1 up to Day 126 | Participants with their ADA titer levels \>=6.23 were considered to be ADA positive. Participants with at least 1 positive ADA titer are reported. |
Countries
Canada, Hong Kong, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 12 |
| 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. | 13 |
| 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. | 12 |
| 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. | 13 |
| 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. | 13 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | ILV-094 100 mg + 50 mg Subcutaneous | ILV-094 200 mg + 100 mg Subcutaneous | Placebo Subcutaneous | ILV-094 300 mg + 150 mg Intravenous | ILV-094 600 mg + 300 mg Intravenous | Placebo Intravenous | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.54 years STANDARD_DEVIATION 12.73 | 45.92 years STANDARD_DEVIATION 10.15 | 44.46 years STANDARD_DEVIATION 14.66 | 48.42 years STANDARD_DEVIATION 14.02 | 47.69 years STANDARD_DEVIATION 8.49 | 42.00 years STANDARD_DEVIATION 15.55 | 44.43 years STANDARD_DEVIATION 12.89 |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 11 Participants | 10 Participants | 11 Participants | 11 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 13 | 9 / 12 | 7 / 13 | 11 / 12 | 9 / 13 | 9 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 0 / 13 | 0 / 12 | 2 / 13 | 0 / 13 |
Outcome results
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.
Time frame: Day 1 up to Day 126
Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 3 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 3 Participants |
| Placebo Subcutaneous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 2 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 3 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 4 Participants |
| Placebo Intravenous | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | 3 Participants |
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.
Time frame: Day 1 up to Day 126
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 10 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 10 Participants |
| Placebo Subcutaneous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 7 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 10 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 7 Participants |
| Placebo Intravenous | Number of Participants With Laboratory Test Values of Potential Clinical Importance | 7 Participants |
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.
Time frame: Day 1 up to Day 126
Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 3 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 9 Participants |
| Placebo Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo Subcutaneous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 7 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 11 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 9 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 2 Participants |
| Placebo Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Placebo Intravenous | Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) | AEs | 9 Participants |
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.
Time frame: Day 1 up to Day 126
Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 2 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 0 Participants |
| Placebo Subcutaneous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 3 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 2 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 5 Participants |
| Placebo Intravenous | Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI) | 4 Participants |
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.
Time frame: Day 1: pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose; Day 42: pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Accumulation Ratio (Rac) of ILV-094 | 2.739 Ratio | Standard Deviation 0.852 |
| ILV-094 200 mg + 100 mg Subcutaneous | Accumulation Ratio (Rac) of ILV-094 | 2.147 Ratio | Standard Deviation 1.283 |
| Placebo Subcutaneous | Accumulation Ratio (Rac) of ILV-094 | 2.134 Ratio | Standard Deviation 0.854 |
| ILV-094 300 mg + 150 mg Intravenous | Accumulation Ratio (Rac) of ILV-094 | 1.684 Ratio | Standard Deviation 0.375 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Apparent Clearance of ILV-094: Multiple Dose | 30.944 Milliliter per hour | Standard Deviation 20.16 |
| ILV-094 200 mg + 100 mg Subcutaneous | Apparent Clearance of ILV-094: Multiple Dose | 22.536 Milliliter per hour | Standard Deviation 11.687 |
| Placebo Subcutaneous | Apparent Clearance of ILV-094: Multiple Dose | 15.092 Milliliter per hour | Standard Deviation 4.832 |
| ILV-094 300 mg + 150 mg Intravenous | Apparent Clearance of ILV-094: Multiple Dose | 15.586 Milliliter per hour | Standard Deviation 5.41 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: PK analysis set. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Apparent Volume of Distribution of ILV-094: Multiple Dose | NA Milliliter | — |
| ILV-094 200 mg + 100 mg Subcutaneous | Apparent Volume of Distribution of ILV-094: Multiple Dose | NA Milliliter | — |
| Placebo Subcutaneous | Apparent Volume of Distribution of ILV-094: Multiple Dose | 7953 Milliliter | Standard Deviation 1996 |
| ILV-094 300 mg + 150 mg Intravenous | Apparent Volume of Distribution of ILV-094: Multiple Dose | 7174 Milliliter | Standard Deviation 2283 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose | 1532 Hour*microgram per milliliter | Standard Deviation 734 |
| ILV-094 200 mg + 100 mg Subcutaneous | Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose | 4241 Hour*microgram per milliliter | Standard Deviation 6434 |
| Placebo Subcutaneous | Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose | 9474 Hour*microgram per milliliter | Standard Deviation 3412 |
| ILV-094 300 mg + 150 mg Intravenous | Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose | 18352 Hour*microgram per milliliter | Standard Deviation 4810 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Population: PK analysis population included participants who received at least 1 dose of ILV-094 with all available plasma concentrations and PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose | 1333 Hour*microgram per milliliter | Standard Deviation 1490 |
| ILV-094 200 mg + 100 mg Subcutaneous | Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose | 4212 Hour*microgram per milliliter | Standard Deviation 7783 |
| Placebo Subcutaneous | Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose | 8880 Hour*microgram per milliliter | Standard Deviation 2554 |
| ILV-094 300 mg + 150 mg Intravenous | Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose | 21358 Hour*microgram per milliliter | Standard Deviation 3696 |
Secondary
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Cavg was the average plasma concentration of drug during the dosing interval.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose | 4.809 Microgram per milliliter | Standard Deviation 2.316 |
| ILV-094 200 mg + 100 mg Subcutaneous | Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose | 13.206 Microgram per milliliter | Standard Deviation 20.301 |
| Placebo Subcutaneous | Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose | 29.580 Microgram per milliliter | Standard Deviation 10.792 |
| ILV-094 300 mg + 150 mg Intravenous | Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose | 57.287 Microgram per milliliter | Standard Deviation 14.946 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose | 7.096 Microgram per milliliter | Standard Deviation 5.138 |
| ILV-094 200 mg + 100 mg Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose | 19.222 Microgram per milliliter | Standard Deviation 29.002 |
| Placebo Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose | 63.133 Microgram per milliliter | Standard Deviation 21.736 |
| ILV-094 300 mg + 150 mg Intravenous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose | 113.523 Microgram per milliliter | Standard Deviation 39.872 |
Secondary
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Population: Pharmacokinetic (PK) analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose | 6.292 Microgram per milliliter | Standard Deviation 6.719 |
| ILV-094 200 mg + 100 mg Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose | 20.151 Microgram per milliliter | Standard Deviation 32.716 |
| Placebo Subcutaneous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose | 79.475 Microgram per milliliter | Standard Deviation 30.964 |
| ILV-094 300 mg + 150 mg Intravenous | Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose | 167.916 Microgram per milliliter | Standard Deviation 32.488 |
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.
Time frame: Baseline, Week 2, 4, 6, 8, 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 0.50 Percent change | Standard Deviation 0.67 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 0.25 Percent change | Standard Deviation 0.62 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 0.82 Percent change | Standard Deviation 0.87 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.46 Percent change | Standard Deviation 0.78 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 0.50 Percent change | Standard Deviation 0.53 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.33 Percent change | Standard Deviation 0.49 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 0.50 Percent change | Standard Deviation 0.67 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 0.60 Percent change | Standard Deviation 0.52 |
| Placebo Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 0.20 Percent change | Standard Deviation 0.42 |
| Placebo Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 0.18 Percent change | Standard Deviation 0.4 |
| Placebo Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.17 Percent change | Standard Deviation 0.39 |
| Placebo Subcutaneous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 0.18 Percent change | Standard Deviation 0.4 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 0.73 Percent change | Standard Deviation 0.9 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 0.45 Percent change | Standard Deviation 0.52 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 0.91 Percent change | Standard Deviation 0.94 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 12 | 1.00 Percent change | Standard Deviation 0.82 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.55 Percent change | Standard Deviation 0.69 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 12 | 1.10 Percent change | Standard Deviation 0.88 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 1.08 Percent change | Standard Deviation 0.67 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.54 Percent change | Standard Deviation 0.52 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 1.08 Percent change | Standard Deviation 0.9 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 1.25 Percent change | Standard Deviation 0.97 |
| Placebo Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 4 | 0.46 Percent change | Standard Deviation 0.66 |
| Placebo Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 8 | 1.00 Percent change | Standard Deviation 0.95 |
| Placebo Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 6 | 0.75 Percent change | Standard Deviation 0.87 |
| Placebo Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 2 | 0.23 Percent change | Standard Deviation 0.44 |
| Placebo Intravenous | Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12 | Week 12 | 0.92 Percent change | Standard Deviation 0.9 |
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).
Time frame: Baseline, Week 2, 4, 6, 8, 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 21.3 Percent change | Standard Deviation 21.6 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 11.4 Percent change | Standard Deviation 19.3 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 13.1 Percent change | Standard Deviation 17.3 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 27.3 Percent change | Standard Deviation 25 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 19.3 Percent change | Standard Deviation 34.3 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 13.5 Percent change | Standard Deviation 18.1 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 24.8 Percent change | Standard Deviation 34 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 28.0 Percent change | Standard Deviation 34.6 |
| Placebo Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 8.71 Percent change | Standard Deviation 16.6 |
| Placebo Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 5.88 Percent change | Standard Deviation 16 |
| Placebo Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 6.36 Percent change | Standard Deviation 10.2 |
| Placebo Subcutaneous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 2.57 Percent change | Standard Deviation 9.29 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 38.4 Percent change | Standard Deviation 38.6 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 13.8 Percent change | Standard Deviation 16.7 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 12 | 38.9 Percent change | Standard Deviation 41.5 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 14.0 Percent change | Standard Deviation 15.8 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 30.3 Percent change | Standard Deviation 30.2 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 12 | 38.3 Percent change | Standard Deviation 30.7 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 32.6 Percent change | Standard Deviation 17.9 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 38.8 Percent change | Standard Deviation 21.4 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 39.4 Percent change | Standard Deviation 25.3 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 20.1 Percent change | Standard Deviation 14.9 |
| Placebo Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 2 | 11.3 Percent change | Standard Deviation 17.9 |
| Placebo Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 8 | 36.7 Percent change | Standard Deviation 39.1 |
| Placebo Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 4 | 21.1 Percent change | Standard Deviation 20.3 |
| Placebo Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 12 | 47.8 Percent change | Standard Deviation 38.4 |
| Placebo Intravenous | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12 | Week 6 | 25.8 Percent change | Standard Deviation 24.1 |
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.
Time frame: Baseline, Week 2, 4, 6, 8, 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 1.83 Percent change | Standard Deviation 2.21 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 0.92 Percent change | Standard Deviation 1.56 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 2.00 Percent change | Standard Deviation 2.83 |
| ILV-094 100 mg + 50 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 1.38 Percent change | Standard Deviation 1.76 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 1.30 Percent change | Standard Deviation 2.26 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 0.75 Percent change | Standard Deviation 1.21 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 1.58 Percent change | Standard Deviation 2.39 |
| ILV-094 200 mg + 100 mg Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 1.80 Percent change | Standard Deviation 2.04 |
| Placebo Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 1.10 Percent change | Standard Deviation 1.2 |
| Placebo Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 1.18 Percent change | Standard Deviation 1.78 |
| Placebo Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 1.00 Percent change | Standard Deviation 1.6 |
| Placebo Subcutaneous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 1.00 Percent change | Standard Deviation 1.48 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 2.50 Percent change | Standard Deviation 2.28 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 1.83 Percent change | Standard Deviation 1.95 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 3.08 Percent change | Standard Deviation 2.68 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 12 | 3.27 Percent change | Standard Deviation 3.47 |
| ILV-094 300 mg + 150 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 1.00 Percent change | Standard Deviation 1.21 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 12 | 3.40 Percent change | Standard Deviation 2.17 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 3.50 Percent change | Standard Deviation 2.24 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 1.69 Percent change | Standard Deviation 1.89 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 3.75 Percent change | Standard Deviation 2.56 |
| ILV-094 600 mg + 300 mg Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 4.17 Percent change | Standard Deviation 2.52 |
| Placebo Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 4 | 2.38 Percent change | Standard Deviation 1.94 |
| Placebo Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 8 | 2.83 Percent change | Standard Deviation 2.48 |
| Placebo Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 6 | 2.92 Percent change | Standard Deviation 2.15 |
| Placebo Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 2 | 1.38 Percent change | Standard Deviation 1.66 |
| Placebo Intravenous | Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12 | Week 12 | 3.75 Percent change | Standard Deviation 2.6 |
Secondary
Serum Amyloid-A Levels
Time frame: Day 1, 14, 28, 42, 56
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Amyloid-A Levels | Day 56 | 9510659 Picogram per milliliter | Standard Deviation 11632879 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Amyloid-A Levels | Day 28 | 16191087 Picogram per milliliter | Standard Deviation 17818430 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Amyloid-A Levels | Day 14 | 26708755 Picogram per milliliter | Standard Deviation 51703518 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Amyloid-A Levels | Day 42 | 21215328 Picogram per milliliter | Standard Deviation 28505898 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Amyloid-A Levels | Day 1 | 26586201 Picogram per milliliter | Standard Deviation 39787546 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Amyloid-A Levels | Day 42 | 19716955 Picogram per milliliter | Standard Deviation 12180775 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Amyloid-A Levels | Day 1 | 33048188 Picogram per milliliter | Standard Deviation 45868899 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Amyloid-A Levels | Day 14 | 37392805 Picogram per milliliter | Standard Deviation 42940021 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Amyloid-A Levels | Day 28 | 26521088 Picogram per milliliter | Standard Deviation 22417132 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Amyloid-A Levels | Day 56 | 27246194 Picogram per milliliter | Standard Deviation 23701114 |
| Placebo Subcutaneous | Serum Amyloid-A Levels | Day 28 | 11795968 Picogram per milliliter | Standard Deviation 5741986 |
| Placebo Subcutaneous | Serum Amyloid-A Levels | Day 1 | 22784245 Picogram per milliliter | Standard Deviation 47173620 |
| Placebo Subcutaneous | Serum Amyloid-A Levels | Day 56 | 17500314 Picogram per milliliter | Standard Deviation 21390091 |
| Placebo Subcutaneous | Serum Amyloid-A Levels | Day 14 | 13930628 Picogram per milliliter | Standard Deviation 9179161 |
| Placebo Subcutaneous | Serum Amyloid-A Levels | Day 42 | 10203678 Picogram per milliliter | Standard Deviation 8878853 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Amyloid-A Levels | Day 28 | 18546404 Picogram per milliliter | Standard Deviation 26651017 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Amyloid-A Levels | Day 1 | 13112923 Picogram per milliliter | Standard Deviation 13655594 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Amyloid-A Levels | Day 14 | 15927358 Picogram per milliliter | Standard Deviation 17100458 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Amyloid-A Levels | Day 42 | 19929741 Picogram per milliliter | Standard Deviation 32444845 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Amyloid-A Levels | Day 56 | 13943320 Picogram per milliliter | Standard Deviation 14583899 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Amyloid-A Levels | Day 42 | 35032152 Picogram per milliliter | Standard Deviation 27565726 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Amyloid-A Levels | Day 1 | 32684269 Picogram per milliliter | Standard Deviation 24358106 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Amyloid-A Levels | Day 56 | 35800358 Picogram per milliliter | Standard Deviation 25684320 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Amyloid-A Levels | Day 14 | 38017589 Picogram per milliliter | Standard Deviation 27662906 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Amyloid-A Levels | Day 28 | 40780444 Picogram per milliliter | Standard Deviation 29197742 |
| Placebo Intravenous | Serum Amyloid-A Levels | Day 1 | 34103493 Picogram per milliliter | Standard Deviation 33363700 |
| Placebo Intravenous | Serum Amyloid-A Levels | Day 42 | 60686782 Picogram per milliliter | Standard Deviation 59133991 |
| Placebo Intravenous | Serum Amyloid-A Levels | Day 14 | 55781761 Picogram per milliliter | Standard Deviation 63622877 |
| Placebo Intravenous | Serum Amyloid-A Levels | Day 56 | 49462769 Picogram per milliliter | Standard Deviation 58393285 |
| Placebo Intravenous | Serum Amyloid-A Levels | Day 28 | 55618175 Picogram per milliliter | Standard Deviation 47529302 |
Comparison: Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.7051ANCOVA
Comparison: Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.1072ANCOVA
Comparison: Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.002ANCOVA
Comparison: Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.0079ANCOVA
Comparison: Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.0308ANCOVA
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.
Time frame: Day 1, 14, 28, 42, 56
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 0.703 Milligram per deciliter | Standard Deviation 0.922 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.742 Milligram per deciliter | Standard Deviation 1.296 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 0.700 Milligram per deciliter | Standard Deviation 1.075 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 0.980 Milligram per deciliter | Standard Deviation 1.372 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 0.927 Milligram per deciliter | Standard Deviation 1.147 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.753 Milligram per deciliter | Standard Deviation 0.666 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 0.826 Milligram per deciliter | Standard Deviation 1.048 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 1.943 Milligram per deciliter | Standard Deviation 3.837 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 1.158 Milligram per deciliter | Standard Deviation 1.783 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 1.001 Milligram per deciliter | Standard Deviation 1.074 |
| Placebo Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.972 Milligram per deciliter | Standard Deviation 1.66 |
| Placebo Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 0.424 Milligram per deciliter | Standard Deviation 0.542 |
| Placebo Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 0.541 Milligram per deciliter | Standard Deviation 0.474 |
| Placebo Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 0.449 Milligram per deciliter | Standard Deviation 0.481 |
| Placebo Subcutaneous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 0.939 Milligram per deciliter | Standard Deviation 2.017 |
| ILV-094 300 mg + 150 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 0.435 Milligram per deciliter | Standard Deviation 0.362 |
| ILV-094 300 mg + 150 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 0.446 Milligram per deciliter | Standard Deviation 0.376 |
| ILV-094 300 mg + 150 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.476 Milligram per deciliter | Standard Deviation 0.399 |
| ILV-094 300 mg + 150 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 0.449 Milligram per deciliter | Standard Deviation 0.493 |
| ILV-094 300 mg + 150 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 0.393 Milligram per deciliter | Standard Deviation 0.365 |
| ILV-094 600 mg + 300 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 0.691 Milligram per deciliter | Standard Deviation 0.777 |
| ILV-094 600 mg + 300 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 0.625 Milligram per deciliter | Standard Deviation 0.672 |
| ILV-094 600 mg + 300 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 0.714 Milligram per deciliter | Standard Deviation 1.121 |
| ILV-094 600 mg + 300 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.587 Milligram per deciliter | Standard Deviation 0.681 |
| ILV-094 600 mg + 300 mg Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 0.684 Milligram per deciliter | Standard Deviation 0.494 |
| Placebo Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 1 | 1.142 Milligram per deciliter | Standard Deviation 1.617 |
| Placebo Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 42 | 1.033 Milligram per deciliter | Standard Deviation 1.447 |
| Placebo Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 14 | 0.978 Milligram per deciliter | Standard Deviation 1.401 |
| Placebo Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 56 | 1.100 Milligram per deciliter | Standard Deviation 1.5 |
| Placebo Intravenous | Serum C-Reactive Protein (CRP) Levels | Day 28 | 0.870 Milligram per deciliter | Standard Deviation 1.089 |
Comparison: Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.5237ANCOVA
Comparison: Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.8463ANCOVA
Comparison: Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.4596ANCOVA
Comparison: Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.6345ANCOVA
Comparison: Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.6235ANCOVA
Secondary
Serum Interleukin-6 (IL-6) Levels
Time frame: Day 1, 14, 28, 42, 56
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 4.40 Picogram per milliliter | Standard Deviation 4.93 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 3.45 Picogram per milliliter | Standard Deviation 3.8 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 3.14 Picogram per milliliter | Standard Deviation 3.46 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 2.43 Picogram per milliliter | Standard Deviation 1.81 |
| ILV-094 100 mg + 50 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 4.17 Picogram per milliliter | Standard Deviation 4.01 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 8.05 Picogram per milliliter | Standard Deviation 9.18 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 8.34 Picogram per milliliter | Standard Deviation 12.37 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 13.05 Picogram per milliliter | Standard Deviation 22.01 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 9.60 Picogram per milliliter | Standard Deviation 11.8 |
| ILV-094 200 mg + 100 mg Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 7.30 Picogram per milliliter | Standard Deviation 6.76 |
| Placebo Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 8.49 Picogram per milliliter | Standard Deviation 15.92 |
| Placebo Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 5.73 Picogram per milliliter | Standard Deviation 6.45 |
| Placebo Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 4.90 Picogram per milliliter | Standard Deviation 2.97 |
| Placebo Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 3.41 Picogram per milliliter | Standard Deviation 3.51 |
| Placebo Subcutaneous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 4.93 Picogram per milliliter | Standard Deviation 6.07 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 2.69 Picogram per milliliter | Standard Deviation 1.87 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 2.66 Picogram per milliliter | Standard Deviation 1.65 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 2.08 Picogram per milliliter | Standard Deviation 0.87 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 2.09 Picogram per milliliter | Standard Deviation 1.31 |
| ILV-094 300 mg + 150 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 2.46 Picogram per milliliter | Standard Deviation 1.47 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 4.32 Picogram per milliliter | Standard Deviation 4.19 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 2.46 Picogram per milliliter | Standard Deviation 1.71 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 6.19 Picogram per milliliter | Standard Deviation 7.71 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 3.36 Picogram per milliliter | Standard Deviation 3.05 |
| ILV-094 600 mg + 300 mg Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 3.51 Picogram per milliliter | Standard Deviation 3.54 |
| Placebo Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 1 | 8.99 Picogram per milliliter | Standard Deviation 18.53 |
| Placebo Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 42 | 10.41 Picogram per milliliter | Standard Deviation 13.26 |
| Placebo Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 14 | 8.16 Picogram per milliliter | Standard Deviation 13.26 |
| Placebo Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 56 | 7.97 Picogram per milliliter | Standard Deviation 12.87 |
| Placebo Intravenous | Serum Interleukin-6 (IL-6) Levels | Day 28 | 8.87 Picogram per milliliter | Standard Deviation 12.65 |
Comparison: Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.3833ANCOVA
Comparison: Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.4909ANCOVA
Comparison: Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.22ANCOVA
Comparison: Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.4183ANCOVA
Comparison: Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.p-value: 0.465ANCOVA
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: PK analysis set. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Multiple Dose | NA Days | — |
| ILV-094 200 mg + 100 mg Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Multiple Dose | NA Days | — |
| Placebo Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Multiple Dose | 15.43 Days | Standard Deviation 2.68 |
| ILV-094 300 mg + 150 mg Intravenous | Terminal Half-Life (t1/2) of ILV-094: Multiple Dose | 13.45 Days | Standard Deviation 3.62 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Population: PK analysis set. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Single Dose | NA Days | — |
| ILV-094 200 mg + 100 mg Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Single Dose | NA Days | — |
| Placebo Subcutaneous | Terminal Half-Life (t1/2) of ILV-094: Single Dose | 10.64 Days | Standard Deviation 1.99 |
| ILV-094 300 mg + 150 mg Intravenous | Terminal Half-Life (t1/2) of ILV-094: Single Dose | 8.69 Days | Standard Deviation 1.42 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: PK analysis set. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose | NA One per day | — |
| ILV-094 200 mg + 100 mg Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose | NA One per day | — |
| Placebo Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose | 0.04554 One per day | Standard Deviation 0.00793 |
| ILV-094 300 mg + 150 mg Intravenous | Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose | 0.05302 One per day | Standard Deviation 0.01163 |
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.
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Population: PK analysis set. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Single Dose | NA One per day | — |
| ILV-094 200 mg + 100 mg Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Single Dose | NA One per day | — |
| Placebo Subcutaneous | Terminal-phase Disposition Rate Constant of ILV-094: Single Dose | 0.06623 One per day | Standard Deviation 0.01438 |
| ILV-094 300 mg + 150 mg Intravenous | Terminal-phase Disposition Rate Constant of ILV-094: Single Dose | 0.08079 One per day | Standard Deviation 0.01501 |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 28, 96,144, 192, 240, 312, 480, 648, 816 hours post-dose on Day 14
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose | 48.07 Hour |
| ILV-094 200 mg + 100 mg Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose | 119.94 Hour |
| Placebo Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose | 2.00 Hour |
| ILV-094 300 mg + 150 mg Intravenous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose | 3.00 Hour |
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
Time frame: Pre-dose, 1, 2, 3, 4, 8, 24, 48, 96, 144, 192, 240, 312 hours post-dose on Day 1
Population: PK analysis population included participants who received at least 1 dose of ILV-094 and had all available plasma concentrations and PK parameters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose | 152.50 Hour |
| ILV-094 200 mg + 100 mg Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose | 107.77 Hour |
| Placebo Subcutaneous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose | 4.00 Hour |
| ILV-094 300 mg + 150 mg Intravenous | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose | 3.00 Hour |
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.
Time frame: Day 1 up to Day 126
Population: Safety analysis population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ILV-094 100 mg + 50 mg Subcutaneous | Number of Participants With Positive Anti-Drug Antibodies Response | 0 Participants |
| ILV-094 200 mg + 100 mg Subcutaneous | Number of Participants With Positive Anti-Drug Antibodies Response | 0 Participants |
| Placebo Subcutaneous | Number of Participants With Positive Anti-Drug Antibodies Response | 0 Participants |
| ILV-094 300 mg + 150 mg Intravenous | Number of Participants With Positive Anti-Drug Antibodies Response | 3 Participants |
| ILV-094 600 mg + 300 mg Intravenous | Number of Participants With Positive Anti-Drug Antibodies Response | 0 Participants |
| Placebo Intravenous | Number of Participants With Positive Anti-Drug Antibodies Response | 1 Participants |