Plaque Psoriasis
Conditions
Keywords
Single dose psoriasis study
Brief summary
The purpose of this research study is to evaluate the safety and tolerability of ILV-095 when it is given to individuals with moderate to severe chronic plaque psoriasis. Another purpose of the study is to observe how the drug enters the blood and tissues over time, how the body breaks down the drug and whether or not the body will develop an immune reaction (sensitivity) to the drug.
Detailed description
B1991002 study is a phase 1 adaptive design study which terminated on 14Mar2011. Regular analyzes of psoriasis assessments conducted per the statistical plan indicate that even if every patient enrolled for the rest of the study respond (up to 23 additional subjects), the study can not meet its primary efficacy endpoint. Pfizer Inc. has terminated the trial and clinical team is asking all clinical investigators to continue collecting safety, pharmacokinetics and pharmacodynamics data until the last subject last visit for all subjects who received test article. Last Subject Last Visit occurred 20May2011.
Interventions
DRUGILV-095 300 mg in a 4 to 1 ratio
Single dose of ILV-095 300 mg
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sexually active men or women must agree to use a medically acceptable form of contraception during the study and continue it for 16 weeks after investigational product administration. * Negative urine pregnancy test result for all women. * Body mass index (BMI) \>=18 kg/m2 and body weight \>=50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/(height \[m\]). * Must meet the following criteria for disease activity, at screening and/or at study entry (subjects who washout from prior therapy may not meet this level of disease activity at screening but must before being entered into the study). * Must have stable moderate to severe chronic plaque psoriasis covering \>=15% of body surface area and be a candidate for systemic therapy or phototherapy. * Psoriasis Area Severity Index (PASI) score of \>11. * Physician Global Assessment (PGA) of psoriasis score \>=3. * Target lesion score \>=6 based on the physician rating of selected sites for erythema, plaque elevation and scaling, with a minimum of 2 on the plaque elevation score. A-12-point score will be used with a 1-4 scale for each domain. Target lesions should not be on the scalp, axillae, face, or groin.
Exclusion criteria
* Presence or history of any disorder that may prevent the successful completion of the study. * Evidence of unstable clinically significant disease (eg, unstable cardiovascular, renal, respiratory, or psychiatric disease or any serious disorder that currently requires physician care). * Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1. * Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * Presence of guttate, erythrodermic, or pustular psoriasis. * Active severe infections within 4 weeks before study day 1. * Systemic malignancy within the past 5 years including melanoma. Treated skin cancer (basal cell carcinoma or squamous cell carcinoma) is excluded. Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD screening should be performed according to local standards using the tuberculin skin test (TST). Any result \>5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should not be taken into account when interpreting a TST result. TST must be performed during the screening period unless one has been performed within the previous 3 months and the results are available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2 | Baseline, Week 2 | PASI score: combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72(maximal disease),with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs:erythema(E),infiltration(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. Percentage of participants with at least 50 percent(%) improvement in total PASI score at Week 2 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method. |
| Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4 | Baseline, Week 4 | PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 4 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method. |
| Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6 | Baseline, Week 6 | PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 6 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method. |
| Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8 | Baseline, Week 8 | PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 8 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance | Baseline (Day 1) up to Week 16 | Criteria for abnormality of potential clinical importance: PR interval: change of \>=20 milliseconds (msec) from baseline value and \>=220 msec; QRS interval: \>=120 msec; corrected QT (QTc) interval (men): \>450 msec and QTc interval (women): \>470 msec. |
| Maximum Observed Serum Concentration (Cmax) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | — |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | — |
| Serum Terminal Half-Life (t1/2) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | t1/2 was the time measured for the serum concentration of ILV-095 to decrease by one half. |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | AUCinf was calculated as AUClast + (Clast/kel), where AUClast was area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (Clast) and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Area Under the Serum Concentration-Time Curve From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | AUClast was the area under the serum concentration versus time curve from time zero to the time of the last quantifiable concentration (Clast). |
| Apparent Clearance (CL/F) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | Clearance was a quantitative measure of the rate at which ILV-095 was removed from the blood (rate at which ILV-095 was metabolized or eliminated by normal biological processes). |
| Target Lesion Score (TLS) | Pre-treatment (Day -1), Week 2, 4, 6, 8 | Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Physician rated each component using the following scale: 0= none, 1= mild, 2= moderate, 3= severe and 4= very severe, where higher scores indicated higher lesion severity. TLS was calculated as the sum of the 3 individual components and TLS total score ranged from 0 (no disease) to 12 (maximal disease severity), where higher scores indicated more severity. |
| Serum Amyloid-A Levels | Baseline, Day 14, 56,112 | Serum amyloid-A (SAA) is a low molecular weight acute phase protein. Serum samples were analyzed for SAA concentrations using solid phase sandwich enzyme-linked immunosorbent assay. The limit of detection (LOD) for SAA assay was 0.21 ng/mL. |
| Plasma Interleukin-6 (IL-6) Levels | Baseline, Day 14, 56,112 | Interleukin: group of naturally occurring proteins that are particularly important in stimulating immune responses such as inflammation. Plasma samples were analyzed for IL-6 concentrations using high sensitive enzyme-linked immunosorbent assay. The limit of detection for IL-6 assay was 0.00002 ng/mL. |
| Plasma Interleukin-22 (IL-22) Levels | Baseline, Day 14, 56,112 | Interleukin: group of naturally occurring proteins that are particularly important in stimulating immune responses such as inflammation. Plasma samples were analyzed for IL-22 concentrations using highly sensitive enzyme-linked immunosorbent assay. The lower limit of quantification for IL-22 assay was 0.34 pg/mL. |
| Serum C-Reactive Protein (CRP) Levels | Baseline, Day 14, 56,112 | CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Serum samples were analyzed for CRP concentrations using nephelometry. |
| Number of Participants With Positive Anti-Drug Antibodies of ILV-095 | Baseline up to Week 16 | The serum samples were analyzed for anti-drug antibodies of ILV-095 by a validated electrochemiluminescence assay and participants with positive anti-drug antibodies were reported in this outcome measure. |
| Number of Participants With Injection-Site Reactions | Baseline up to Week 16 | Injection site reactions included following symptoms: injection site itching, injection site redness, injection-site swelling, injection site pain, injection site ulceration, requirement for plastic surgery associated with an injection. |
| Apparent Volume of Distribution (Vz/F) of ILV-095 | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose | Apparent volume of distribution was defined as the theoretical volume in which the total amount of ILV-095 was needed to be uniformly distributed to produce the desired serum concentration of ILV-095. |
| Physician Global Assessment (PGA) Score of Psoriasis | Pre-treatment (Day -1), Week 2, 4, 6, 8 | PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; infiltration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total score divided by 3) was calculated. The average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was ranging from: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher scores indicated more severity. |
| Number of Participants With Laboratory Abnormalities of Potential Clinical Importance | Baseline (Day 1) up to Week 16 | Hematology (decrease of greater than or equal to \[\>=\] 5% hematocrit, hemoglobin \>=20 gram per liter \[g/L\]; white blood cell less than \[\<\] 3.0\*10\^9/L; neutrophil \<1.5\*10\^9/L; platelet \<100\*10\^9 /L; eosinophil greater than \[\>\] 0.5\*10\^9/L); coagulation (prothrombin, partial thromboplastin time \>1.5\*upper limit of normal \[ULN\]); chemistry (above ULN or below lower limit of normal \[LLN\] for \[sodium \>5 millimole per liter {mmol/L}; potassium \>0.5 mmol/L; glucose {fasting} \>0.83 mmol/L; glucose {non fasting} \>5.0 mmol/L; phosphorus \>0.162 mmol/L\]; creatinine \>1.36\*ULN; blood urea nitrogen/urea \>1.5\*ULN; creatine kinase \>3\*ULN; change from baseline in \[calcium \>=0.25 mmol/L; magnesium \>=0.21 mmol/L; total protein \>=20 g/L; albumin \>=10 g/L; uric acid \>0.119 mmol/L\]; fasting \[cholesterol \>7.77 mmol/L; triglyceride \>3.39 mmol/L\]); liver test (alanine amino \[A\] transferase \[T\], aspartate AT, total bilirubin \>2\*ULN; alkaline phosphatase \>1.5\*ULN; gamma glutamyl T, lactate dehydrogenase \>3\*ULN). |
| Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance | Baseline (Day 1) up to Week 16 | Sitting and supine systolic blood pressure (BP): increase of \>=20 millimeter mercury (mm Hg) from baseline value and \>=160 mm Hg; decrease of \>=20 mm Hg from baseline value and less than or equal to (\<=) 90 mm Hg. Diastolic BP: increase of \>=15 mm Hg from baseline value and \>=100 mm Hg; decrease of \>=15 mm Hg from baseline value and \<=50 mm Hg. Heart rate: increase of \>15 beats per minute (bpm) from baseline value and \>=120 bpm; decrease of \>15 bpm from baseline value and \<=45 bpm. Orthostatic (supine to standing): 1) systolic BP: decrease of \>=20 mm Hg from supine value; 2) diastolic BP: decrease of \>=20 mm Hg from supine value; 3) heart rate: increase of \>=30 bpm from supine value. Oral temperature \<35 degree Celsius or \>38.3 degree Celsius. Respiratory rate \<10 breaths per minute; \>25 breaths per minute. Weight \>=7% increase or decrease from baseline value. |
Countries
Canada, United States
Participant flow
Pre-assignment details
The study was early terminated based on the outcome of interim analysis which was conducted when data from 39 participants was available. At the time of study termination, 30 participants had received 300 milligram (mg) of ILV-095, 8 participants had received placebo, and 1 participant had received 100 mg of ILV-095.
Participants by arm
| Arm | Count |
|---|---|
| ILV-095 100 mg Participants received single dose of ILV-095 100 mg subcutaneously on Day 1 and were followed up to Week 16. | 1 |
| ILV-095 300 mg Participants received single dose of ILV-095 300 mg subcutaneously on Day 1 and were followed up to Week 16. | 30 |
| Placebo Participants received single dose of placebo matching to ILV-095 subcutaneously on Day 1 and were followed up to Week 16. | 8 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | ILV-095 100 mg | ILV-095 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 27.00 years STANDARD_DEVIATION 0 | 46.23 years STANDARD_DEVIATION 12.94 | 44.63 years STANDARD_DEVIATION 8.9 | 45.41 years STANDARD_DEVIATION 12.33 |
| Sex: Female, Male Female | 0 Participants | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 24 Participants | 5 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 22 / 30 | 7 / 8 |
| serious Total, serious adverse events | 0 / 1 | 1 / 30 | 0 / 8 |
Outcome results
Primary
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2
PASI score: combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72(maximal disease),with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs:erythema(E),infiltration(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. Percentage of participants with at least 50 percent(%) improvement in total PASI score at Week 2 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Time frame: Baseline, Week 2
Population: Intent-to-treat (ITT) population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, Number of Participants Analyzed (N) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2 | 0 percentage of participants |
| ILV-095 300 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2 | 13.8 percentage of participants |
| Placebo | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2 | 14.3 percentage of participants |
Primary
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 4 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Time frame: Baseline, Week 4
Population: ITT population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, N signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4 | 0 percentage of participants |
| ILV-095 300 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4 | 28.6 percentage of participants |
| Placebo | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4 | 28.6 percentage of participants |
Primary
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 6 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Time frame: Baseline, Week 6
Population: ITT population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, N signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6 | 0 percentage of participants |
| ILV-095 300 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6 | 25.0 percentage of participants |
| Placebo | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6 | 33.3 percentage of participants |
Primary
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing 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 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(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. Percentage of participants with at least 50% improvement in total PASI score at Week 8 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Time frame: Baseline, Week 8
Population: ITT population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, N signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8 | 0 percentage of participants |
| ILV-095 300 mg | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8 | 33.3 percentage of participants |
| Placebo | Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8 | 16.7 percentage of participants |
Other Pre-specified
Apparent Clearance (CL/F) of ILV-095
Clearance was a quantitative measure of the rate at which ILV-095 was removed from the blood (rate at which ILV-095 was metabolized or eliminated by normal biological processes).
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest. Here, N signifies number of participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Apparent Clearance (CL/F) of ILV-095 | 0.0197 liter per hour (L/hr) | — |
| ILV-095 300 mg | Apparent Clearance (CL/F) of ILV-095 | 0.02275 liter per hour (L/hr) | Standard Deviation 0.022558 |
Other Pre-specified
Apparent Volume of Distribution (Vz/F) of ILV-095
Apparent volume of distribution was defined as the theoretical volume in which the total amount of ILV-095 was needed to be uniformly distributed to produce the desired serum concentration of ILV-095.
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest. Here, N signifies number of participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Apparent Volume of Distribution (Vz/F) of ILV-095 | 8.90 liter | — |
| ILV-095 300 mg | Apparent Volume of Distribution (Vz/F) of ILV-095 | 11.83 liter | Standard Deviation 10.656 |
Other Pre-specified
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ILV-095
AUCinf was calculated as AUClast + (Clast/kel), where AUClast was area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (Clast) and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest. Here, N signifies number of participants who were evaluable for this measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ILV-095 | 5070 microgram*hour per milliliter | — |
| ILV-095 300 mg | Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ILV-095 | 13200 microgram*hour per milliliter | Standard Deviation 6828.5 |
Other Pre-specified
Area Under the Serum Concentration-Time Curve From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of ILV-095
AUClast was the area under the serum concentration versus time curve from time zero to the time of the last quantifiable concentration (Clast).
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Area Under the Serum Concentration-Time Curve From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of ILV-095 | 5040 microgram*hour per milliliter | — |
| ILV-095 300 mg | Area Under the Serum Concentration-Time Curve From Time Zero to Time of The Last Quantifiable Concentration (AUClast) of ILV-095 | 12190 microgram*hour per milliliter | Standard Deviation 6803.3 |
Other Pre-specified
Maximum Observed Serum Concentration (Cmax) of ILV-095
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: Pharmacokinetic (PK) parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Maximum Observed Serum Concentration (Cmax) of ILV-095 | 7.39 microgram per milliliter (mcg/mL) | — |
| ILV-095 300 mg | Maximum Observed Serum Concentration (Cmax) of ILV-095 | 19.25 microgram per milliliter (mcg/mL) | Standard Deviation 8.1558 |
Other Pre-specified
Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance
Criteria for abnormality of potential clinical importance: PR interval: change of \>=20 milliseconds (msec) from baseline value and \>=220 msec; QRS interval: \>=120 msec; corrected QT (QTc) interval (men): \>450 msec and QTc interval (women): \>470 msec.
Time frame: Baseline (Day 1) up to Week 16
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance | 1 participants |
| ILV-095 300 mg | Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance | 24 participants |
| Placebo | Number of Participants With Electrocardiograms (ECG) Abnormalities of Potential Clinical Importance | 8 participants |
Other Pre-specified
Number of Participants With Injection-Site Reactions
Injection site reactions included following symptoms: injection site itching, injection site redness, injection-site swelling, injection site pain, injection site ulceration, requirement for plastic surgery associated with an injection.
Time frame: Baseline up to Week 16
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Number of Participants With Injection-Site Reactions | 0 participants |
| ILV-095 300 mg | Number of Participants With Injection-Site Reactions | 0 participants |
| Placebo | Number of Participants With Injection-Site Reactions | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities of Potential Clinical Importance
Hematology (decrease of greater than or equal to \[\>=\] 5% hematocrit, hemoglobin \>=20 gram per liter \[g/L\]; white blood cell less than \[\<\] 3.0\*10\^9/L; neutrophil \<1.5\*10\^9/L; platelet \<100\*10\^9 /L; eosinophil greater than \[\>\] 0.5\*10\^9/L); coagulation (prothrombin, partial thromboplastin time \>1.5\*upper limit of normal \[ULN\]); chemistry (above ULN or below lower limit of normal \[LLN\] for \[sodium \>5 millimole per liter {mmol/L}; potassium \>0.5 mmol/L; glucose {fasting} \>0.83 mmol/L; glucose {non fasting} \>5.0 mmol/L; phosphorus \>0.162 mmol/L\]; creatinine \>1.36\*ULN; blood urea nitrogen/urea \>1.5\*ULN; creatine kinase \>3\*ULN; change from baseline in \[calcium \>=0.25 mmol/L; magnesium \>=0.21 mmol/L; total protein \>=20 g/L; albumin \>=10 g/L; uric acid \>0.119 mmol/L\]; fasting \[cholesterol \>7.77 mmol/L; triglyceride \>3.39 mmol/L\]); liver test (alanine amino \[A\] transferase \[T\], aspartate AT, total bilirubin \>2\*ULN; alkaline phosphatase \>1.5\*ULN; gamma glutamyl T, lactate dehydrogenase \>3\*ULN).
Time frame: Baseline (Day 1) up to Week 16
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Number of Participants With Laboratory Abnormalities of Potential Clinical Importance | 1 participants |
| ILV-095 300 mg | Number of Participants With Laboratory Abnormalities of Potential Clinical Importance | 19 participants |
| Placebo | Number of Participants With Laboratory Abnormalities of Potential Clinical Importance | 6 participants |
Other Pre-specified
Number of Participants With Positive Anti-Drug Antibodies of ILV-095
The serum samples were analyzed for anti-drug antibodies of ILV-095 by a validated electrochemiluminescence assay and participants with positive anti-drug antibodies were reported in this outcome measure.
Time frame: Baseline up to Week 16
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Number of Participants With Positive Anti-Drug Antibodies of ILV-095 | 0 participants |
| ILV-095 300 mg | Number of Participants With Positive Anti-Drug Antibodies of ILV-095 | 16 participants |
| Placebo | Number of Participants With Positive Anti-Drug Antibodies of ILV-095 | 0 participants |
Other Pre-specified
Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance
Sitting and supine systolic blood pressure (BP): increase of \>=20 millimeter mercury (mm Hg) from baseline value and \>=160 mm Hg; decrease of \>=20 mm Hg from baseline value and less than or equal to (\<=) 90 mm Hg. Diastolic BP: increase of \>=15 mm Hg from baseline value and \>=100 mm Hg; decrease of \>=15 mm Hg from baseline value and \<=50 mm Hg. Heart rate: increase of \>15 beats per minute (bpm) from baseline value and \>=120 bpm; decrease of \>15 bpm from baseline value and \<=45 bpm. Orthostatic (supine to standing): 1) systolic BP: decrease of \>=20 mm Hg from supine value; 2) diastolic BP: decrease of \>=20 mm Hg from supine value; 3) heart rate: increase of \>=30 bpm from supine value. Oral temperature \<35 degree Celsius or \>38.3 degree Celsius. Respiratory rate \<10 breaths per minute; \>25 breaths per minute. Weight \>=7% increase or decrease from baseline value.
Time frame: Baseline (Day 1) up to Week 16
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ILV-095 100 mg | Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance | 0 participants |
| ILV-095 300 mg | Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance | 6 participants |
| Placebo | Number of Participants With Vital Sign Abnormalities of Potential Clinical Importance | 2 participants |
Other Pre-specified
Physician Global Assessment (PGA) Score of Psoriasis
PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; infiltration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total score divided by 3) was calculated. The average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was ranging from: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher scores indicated more severity.
Time frame: Pre-treatment (Day -1), Week 2, 4, 6, 8
Population: ITT population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 6 | 3.00 units on a scale | — |
| ILV-095 100 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 4 | 3.00 units on a scale | — |
| ILV-095 100 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 2 | 3.00 units on a scale | — |
| ILV-095 100 mg | Physician Global Assessment (PGA) Score of Psoriasis | Day -1 | 4.00 units on a scale | — |
| ILV-095 100 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 8 | 3.00 units on a scale | — |
| ILV-095 300 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 4 | 2.25 units on a scale | Standard Deviation 0.97 |
| ILV-095 300 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 2 | 2.52 units on a scale | Standard Deviation 0.87 |
| ILV-095 300 mg | Physician Global Assessment (PGA) Score of Psoriasis | Day -1 | 3.23 units on a scale | Standard Deviation 0.43 |
| ILV-095 300 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 6 | 2.18 units on a scale | Standard Deviation 0.98 |
| ILV-095 300 mg | Physician Global Assessment (PGA) Score of Psoriasis | Week 8 | 2.37 units on a scale | Standard Deviation 1.01 |
| Placebo | Physician Global Assessment (PGA) Score of Psoriasis | Week 8 | 2.71 units on a scale | Standard Deviation 0.76 |
| Placebo | Physician Global Assessment (PGA) Score of Psoriasis | Week 6 | 2.86 units on a scale | Standard Deviation 0.69 |
| Placebo | Physician Global Assessment (PGA) Score of Psoriasis | Day -1 | 3.38 units on a scale | Standard Deviation 0.52 |
| Placebo | Physician Global Assessment (PGA) Score of Psoriasis | Week 4 | 2.63 units on a scale | Standard Deviation 0.92 |
| Placebo | Physician Global Assessment (PGA) Score of Psoriasis | Week 2 | 3.00 units on a scale | Standard Deviation 0.76 |
Other Pre-specified
Plasma Interleukin-22 (IL-22) Levels
Interleukin: group of naturally occurring proteins that are particularly important in stimulating immune responses such as inflammation. Plasma samples were analyzed for IL-22 concentrations using highly sensitive enzyme-linked immunosorbent assay. The lower limit of quantification for IL-22 assay was 0.34 pg/mL.
Time frame: Baseline, Day 14, 56,112
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication. Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Plasma Interleukin-22 (IL-22) Levels | Baseline | 636.9 picogram per milliliter (pg/mL) | — |
| ILV-095 100 mg | Plasma Interleukin-22 (IL-22) Levels | Day 14 | 5688.3 picogram per milliliter (pg/mL) | — |
| ILV-095 100 mg | Plasma Interleukin-22 (IL-22) Levels | Day 56 | 7412.3 picogram per milliliter (pg/mL) | — |
| ILV-095 100 mg | Plasma Interleukin-22 (IL-22) Levels | Day 112 | 2202.4 picogram per milliliter (pg/mL) | — |
| ILV-095 300 mg | Plasma Interleukin-22 (IL-22) Levels | Day 112 | 3471.3 picogram per milliliter (pg/mL) | Standard Deviation 2368 |
| ILV-095 300 mg | Plasma Interleukin-22 (IL-22) Levels | Baseline | 334.4 picogram per milliliter (pg/mL) | Standard Deviation 352.7 |
| ILV-095 300 mg | Plasma Interleukin-22 (IL-22) Levels | Day 56 | 2886.6 picogram per milliliter (pg/mL) | Standard Deviation 2260.5 |
| ILV-095 300 mg | Plasma Interleukin-22 (IL-22) Levels | Day 14 | 1273.9 picogram per milliliter (pg/mL) | Standard Deviation 1642.4 |
| Placebo | Plasma Interleukin-22 (IL-22) Levels | Day 112 | 363.1 picogram per milliliter (pg/mL) | Standard Deviation 273.6 |
| Placebo | Plasma Interleukin-22 (IL-22) Levels | Day 14 | 733.3 picogram per milliliter (pg/mL) | Standard Deviation 708.4 |
| Placebo | Plasma Interleukin-22 (IL-22) Levels | Day 56 | 552.0 picogram per milliliter (pg/mL) | Standard Deviation 377.5 |
| Placebo | Plasma Interleukin-22 (IL-22) Levels | Baseline | 1150.4 picogram per milliliter (pg/mL) | Standard Deviation 1229.3 |
Other Pre-specified
Plasma Interleukin-6 (IL-6) Levels
Interleukin: group of naturally occurring proteins that are particularly important in stimulating immune responses such as inflammation. Plasma samples were analyzed for IL-6 concentrations using high sensitive enzyme-linked immunosorbent assay. The limit of detection for IL-6 assay was 0.00002 ng/mL.
Time frame: Baseline, Day 14, 56,112
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication. Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Plasma Interleukin-6 (IL-6) Levels | Baseline | 4.7 nanogram per liter (ng/L) | — |
| ILV-095 100 mg | Plasma Interleukin-6 (IL-6) Levels | Day 14 | 6.0 nanogram per liter (ng/L) | — |
| ILV-095 100 mg | Plasma Interleukin-6 (IL-6) Levels | Day 56 | 4.7 nanogram per liter (ng/L) | — |
| ILV-095 100 mg | Plasma Interleukin-6 (IL-6) Levels | Day 112 | 5.4 nanogram per liter (ng/L) | — |
| ILV-095 300 mg | Plasma Interleukin-6 (IL-6) Levels | Day 112 | 4.5 nanogram per liter (ng/L) | Standard Deviation 4.4 |
| ILV-095 300 mg | Plasma Interleukin-6 (IL-6) Levels | Baseline | 4.8 nanogram per liter (ng/L) | Standard Deviation 7.6 |
| ILV-095 300 mg | Plasma Interleukin-6 (IL-6) Levels | Day 56 | 4.8 nanogram per liter (ng/L) | Standard Deviation 5.5 |
| ILV-095 300 mg | Plasma Interleukin-6 (IL-6) Levels | Day 14 | 5.5 nanogram per liter (ng/L) | Standard Deviation 6.8 |
| Placebo | Plasma Interleukin-6 (IL-6) Levels | Day 112 | 2.6 nanogram per liter (ng/L) | Standard Deviation 1.5 |
| Placebo | Plasma Interleukin-6 (IL-6) Levels | Day 14 | 3.4 nanogram per liter (ng/L) | Standard Deviation 2.6 |
| Placebo | Plasma Interleukin-6 (IL-6) Levels | Day 56 | 2.9 nanogram per liter (ng/L) | Standard Deviation 1.3 |
| Placebo | Plasma Interleukin-6 (IL-6) Levels | Baseline | 3.6 nanogram per liter (ng/L) | Standard Deviation 2.4 |
Other Pre-specified
Serum Amyloid-A Levels
Serum amyloid-A (SAA) is a low molecular weight acute phase protein. Serum samples were analyzed for SAA concentrations using solid phase sandwich enzyme-linked immunosorbent assay. The limit of detection (LOD) for SAA assay was 0.21 ng/mL.
Time frame: Baseline, Day 14, 56,112
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication. Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Serum Amyloid-A Levels | Baseline | 53753.0 nanogram per milliliter (ng/mL) | — |
| ILV-095 100 mg | Serum Amyloid-A Levels | Day 14 | 74142.0 nanogram per milliliter (ng/mL) | — |
| ILV-095 100 mg | Serum Amyloid-A Levels | Day 56 | 114900.0 nanogram per milliliter (ng/mL) | — |
| ILV-095 100 mg | Serum Amyloid-A Levels | Day 112 | 62092.0 nanogram per milliliter (ng/mL) | — |
| ILV-095 300 mg | Serum Amyloid-A Levels | Day 112 | 38173.3 nanogram per milliliter (ng/mL) | Standard Deviation 29227.6 |
| ILV-095 300 mg | Serum Amyloid-A Levels | Baseline | 53161.8 nanogram per milliliter (ng/mL) | Standard Deviation 86984.7 |
| ILV-095 300 mg | Serum Amyloid-A Levels | Day 56 | 45934.9 nanogram per milliliter (ng/mL) | Standard Deviation 62741.2 |
| ILV-095 300 mg | Serum Amyloid-A Levels | Day 14 | 64341.8 nanogram per milliliter (ng/mL) | Standard Deviation 121231.2 |
| Placebo | Serum Amyloid-A Levels | Day 112 | 25537.1 nanogram per milliliter (ng/mL) | Standard Deviation 9639.5 |
| Placebo | Serum Amyloid-A Levels | Day 14 | 27118.9 nanogram per milliliter (ng/mL) | Standard Deviation 14287.6 |
| Placebo | Serum Amyloid-A Levels | Day 56 | 40405.6 nanogram per milliliter (ng/mL) | Standard Deviation 55721.3 |
| Placebo | Serum Amyloid-A Levels | Baseline | 24316.5 nanogram per milliliter (ng/mL) | Standard Deviation 14098.6 |
Other Pre-specified
Serum C-Reactive Protein (CRP) Levels
CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Serum samples were analyzed for CRP concentrations using nephelometry.
Time frame: Baseline, Day 14, 56,112
Population: Safety population included all randomly assigned participants who took at least 1 dose of study medication. Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Serum C-Reactive Protein (CRP) Levels | Baseline | 11.2 milligram per liter (mg/L) | — |
| ILV-095 100 mg | Serum C-Reactive Protein (CRP) Levels | Day 14 | 9.6 milligram per liter (mg/L) | — |
| ILV-095 100 mg | Serum C-Reactive Protein (CRP) Levels | Day 56 | 13.0 milligram per liter (mg/L) | — |
| ILV-095 100 mg | Serum C-Reactive Protein (CRP) Levels | Day 112 | 12.1 milligram per liter (mg/L) | — |
| ILV-095 300 mg | Serum C-Reactive Protein (CRP) Levels | Day 112 | 6.1 milligram per liter (mg/L) | Standard Deviation 3.2 |
| ILV-095 300 mg | Serum C-Reactive Protein (CRP) Levels | Baseline | 7.2 milligram per liter (mg/L) | Standard Deviation 6.7 |
| ILV-095 300 mg | Serum C-Reactive Protein (CRP) Levels | Day 56 | 6.4 milligram per liter (mg/L) | Standard Deviation 6.7 |
| ILV-095 300 mg | Serum C-Reactive Protein (CRP) Levels | Day 14 | 9.1 milligram per liter (mg/L) | Standard Deviation 10.9 |
| Placebo | Serum C-Reactive Protein (CRP) Levels | Day 112 | 4.6 milligram per liter (mg/L) | Standard Deviation 1.8 |
| Placebo | Serum C-Reactive Protein (CRP) Levels | Day 14 | 5.0 milligram per liter (mg/L) | Standard Deviation 1.9 |
| Placebo | Serum C-Reactive Protein (CRP) Levels | Day 56 | 4.9 milligram per liter (mg/L) | Standard Deviation 2.2 |
| Placebo | Serum C-Reactive Protein (CRP) Levels | Baseline | 4.7 milligram per liter (mg/L) | Standard Deviation 1.9 |
Other Pre-specified
Serum Terminal Half-Life (t1/2) of ILV-095
t1/2 was the time measured for the serum concentration of ILV-095 to decrease by one half.
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest. Here, N signifies number of participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ILV-095 100 mg | Serum Terminal Half-Life (t1/2) of ILV-095 | 13.0 days | — |
| ILV-095 300 mg | Serum Terminal Half-Life (t1/2) of ILV-095 | 15.40 days | Standard Deviation 2.7272 |
Other Pre-specified
Target Lesion Score (TLS)
Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Physician rated each component using the following scale: 0= none, 1= mild, 2= moderate, 3= severe and 4= very severe, where higher scores indicated higher lesion severity. TLS was calculated as the sum of the 3 individual components and TLS total score ranged from 0 (no disease) to 12 (maximal disease severity), where higher scores indicated more severity.
Time frame: Pre-treatment (Day -1), Week 2, 4, 6, 8
Population: ITT population included all randomly assigned participants who took at least 1 dose of study medication and had at least 1 clinical activity measurement (PASI score). Here, n signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ILV-095 100 mg | Target Lesion Score (TLS) | Week 6 | 6.00 units on a scale | — |
| ILV-095 100 mg | Target Lesion Score (TLS) | Week 4 | 6.00 units on a scale | — |
| ILV-095 100 mg | Target Lesion Score (TLS) | Day -1 | 9.00 units on a scale | — |
| ILV-095 100 mg | Target Lesion Score (TLS) | Week 2 | 8.00 units on a scale | — |
| ILV-095 100 mg | Target Lesion Score (TLS) | Week 8 | 4.00 units on a scale | — |
| ILV-095 300 mg | Target Lesion Score (TLS) | Week 4 | 5.11 units on a scale | Standard Deviation 2.6 |
| ILV-095 300 mg | Target Lesion Score (TLS) | Day -1 | 7.77 units on a scale | Standard Deviation 1.41 |
| ILV-095 300 mg | Target Lesion Score (TLS) | Week 2 | 5.93 units on a scale | Standard Deviation 2.33 |
| ILV-095 300 mg | Target Lesion Score (TLS) | Week 6 | 4.64 units on a scale | Standard Deviation 3.02 |
| ILV-095 300 mg | Target Lesion Score (TLS) | Week 8 | 4.63 units on a scale | Standard Deviation 3.05 |
| Placebo | Target Lesion Score (TLS) | Week 8 | 5.29 units on a scale | Standard Deviation 2.98 |
| Placebo | Target Lesion Score (TLS) | Week 6 | 4.43 units on a scale | Standard Deviation 2.88 |
| Placebo | Target Lesion Score (TLS) | Day -1 | 8.13 units on a scale | Standard Deviation 0.83 |
| Placebo | Target Lesion Score (TLS) | Week 4 | 4.75 units on a scale | Standard Deviation 2.87 |
| Placebo | Target Lesion Score (TLS) | Week 2 | 6.63 units on a scale | Standard Deviation 2.26 |
Other Pre-specified
Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095
Time frame: Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose
Population: PK parameter analysis population included all randomly assigned participants who took at least 1 dose of ILV-095 and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ILV-095 100 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095 | 2.01 days |
| ILV-095 300 mg | Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095 | 5.98 days |