ClinicalTrials.gg
Sign In
CompletedNCT00563524Updated Aug 23, 2024Results posted

Study Evaluating The Safety And Tolerability Of ILV-094 In Subjects With Psoriasis

A Phase 1 interventional study of ILV-094 in Psoriasis, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess safety, and tolerability of multiple doses of ILV-094 administered to subjects with psoriasis

02

Conditions studied

  • Psoriasis

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 76 is close to the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Browse Wyeth studies →All Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Use of any 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.
  • 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 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.)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Placebo comparator
    1

    Drug: ILV-094

Interventions

  • DrugILV-094

    SC and IV administration on days 1, 14, 28, and 42

    Also known as: placebo

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Accumulation Ratio (Rac) of ILV-094

    Rac was estimated as: X\*AUClast of Day 1 divided by AUC312 of Day 42, where X is the ratio of the maintenance dose to the loading dose of ILV-094, AUClast is defined as area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration and AUC-312 is the AUC from time 0 to 312 hours on Day 42.

    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

  15. 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

  16. Serum Interleukin-6 (IL-6) Levels

    Time frame: Day 1, 14, 28, 42, 56

  17. Serum Amyloid-A Levels

    Time frame: Day 1, 14, 28, 42, 56

  18. 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

  19. 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

  20. 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

Other outcomes

  1. 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

07

Results

Posted Aug 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Started131213121313
Completed11910121112
Not completed233021
Withdrew: Adverse event010020
Withdrew: Lost to follow-up100000
Withdrew: Protocol violation010000
Withdrew: Withdrawal by subject113001

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
ParticipantsILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
AEs3971199
SAEs000020
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
ParticipantsILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters332343
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)
ParticipantsILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Number of Participants With Vital Sign Values of Potential Clinical Importance (PCI)203254
PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Test Values of Potential Clinical Importance
ParticipantsILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Number of Participants With Laboratory Test Values of Potential Clinical Importance101071077
SecondaryMaximum 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
Reported as:
Geometric mean · Microgram per milliliter
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose
Microgram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Single Dose6.292 ± 6.71920.151 ± 32.71679.475 ± 30.964167.916 ± 32.488
SecondaryMaximum 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
Reported as:
Geometric mean · Microgram per milliliter
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose
Microgram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Maximum Observed Plasma Concentration (Cmax) of ILV-094: Multiple Dose7.096 ± 5.13819.222 ± 29.00263.133 ± 21.736113.523 ± 39.872
SecondaryTime 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
Reported as:
Median · Hour
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose
HourILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Single Dose152.50 (48.0 to 263.9)107.77 (48.5 to 310.3)4.00 (1.0 to 314.1)3.00 (1.0 to 4.0)
SecondaryTime 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
Reported as:
Median · Hour
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose
HourILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ILV-094: Multiple Dose48.07 (8.0 to 215.6)119.94 (47.2 to 263.8)2.00 (1.0 to 4.0)3.00 (0.0 to 24.0)
SecondaryTerminal-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
Reported as:
Geometric mean · One per day
Terminal-phase Disposition Rate Constant of ILV-094: Single Dose
One per dayILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Terminal-phase Disposition Rate Constant of ILV-094: Single DoseNA ± NANA ± NA0.06623 ± 0.014380.08079 ± 0.01501
SecondaryTerminal-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
Reported as:
Geometric mean · One per day
Terminal-phase Disposition Rate Constant of ILV-094: Multiple Dose
One per dayILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Terminal-phase Disposition Rate Constant of ILV-094: Multiple DoseNA ± NANA ± NA0.04554 ± 0.007930.05302 ± 0.01163
SecondaryTerminal 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
Reported as:
Mean · Days
Terminal Half-Life (t1/2) of ILV-094: Single Dose
DaysILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Terminal Half-Life (t1/2) of ILV-094: Single DoseNA ± NANA ± NA10.64 ± 1.998.69 ± 1.42
SecondaryTerminal 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
Reported as:
Mean · Days
Terminal Half-Life (t1/2) of ILV-094: Multiple Dose
DaysILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Terminal Half-Life (t1/2) of ILV-094: Multiple DoseNA ± NANA ± NA15.43 ± 2.6813.45 ± 3.62
SecondaryArea 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
Reported as:
Geometric mean · Hour*microgram per milliliter
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose
Hour*microgram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Area Under the Curve From Time Zero to The Time of Last Quantifiable Concentration (AUClast) of ILV-094: Single Dose1333 ± 14904212 ± 77838880 ± 255421358 ± 3696
SecondaryArea 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
Reported as:
Geometric mean · Hour*microgram per milliliter
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose
Hour*microgram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Area Under the Curve From Time Zero to 312 Hours [AUC (0-312)] Postdose of ILV-094: Multiple Dose1532 ± 7344241 ± 64349474 ± 341218352 ± 4810
SecondaryApparent 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
Reported as:
Geometric mean · Milliliter per hour
Apparent Clearance of ILV-094: Multiple Dose
Milliliter per hourILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Apparent Clearance of ILV-094: Multiple Dose30.944 ± 20.16022.536 ± 11.68715.092 ± 4.83215.586 ± 5.410
SecondaryApparent 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
Reported as:
Geometric mean · Milliliter
Apparent Volume of Distribution of ILV-094: Multiple Dose
MilliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Apparent Volume of Distribution of ILV-094: Multiple DoseNA ± NANA ± NA7953 ± 19967174 ± 2283
SecondaryAverage 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
Reported as:
Geometric mean · Microgram per milliliter
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose
Microgram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Average Observed Plasma Concentration (Cavg) of ILV-094: Multiple Dose4.809 ± 2.31613.206 ± 20.30129.580 ± 10.79257.287 ± 14.946
SecondaryAccumulation 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
Reported as:
Geometric mean · Ratio
Accumulation Ratio (Rac) of ILV-094
RatioILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg Intravenous
Accumulation Ratio (Rac) of ILV-0942.739 ± 0.8522.147 ± 1.2832.134 ± 0.8541.684 ± 0.375
SecondarySerum 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
Reported as:
Mean · Milligram per deciliter
Serum C-Reactive Protein (CRP) Levels
Milligram per deciliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Day 10.700 ± 1.0751.943 ± 3.8370.939 ± 2.0170.446 ± 0.3760.625 ± 0.6721.142 ± 1.617
Day 140.742 ± 1.2960.753 ± 0.6660.972 ± 1.6600.476 ± 0.3990.587 ± 0.6810.978 ± 1.401
Day 280.927 ± 1.1471.001 ± 1.0740.449 ± 0.4810.435 ± 0.3620.684 ± 0.4940.870 ± 1.089
Day 420.703 ± 0.9220.826 ± 1.0480.424 ± 0.5420.449 ± 0.4930.691 ± 0.7771.033 ± 1.447
Day 560.980 ± 1.3721.158 ± 1.7830.541 ± 0.4740.393 ± 0.3650.714 ± 1.1211.100 ± 1.500
Statistical analysis
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.5237
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.8463
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.4596
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.6345
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.6235
SecondarySerum Interleukin-6 (IL-6) Levels
Time frame:
Day 1, 14, 28, 42, 56
Reported as:
Mean · Picogram per milliliter
Serum Interleukin-6 (IL-6) Levels
Picogram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Day 13.14 ± 3.4613.05 ± 22.014.93 ± 6.072.66 ± 1.652.46 ± 1.718.99 ± 18.53
Day 143.45 ± 3.808.05 ± 9.188.49 ± 15.922.08 ± 0.873.36 ± 3.058.16 ± 13.26
Day 284.17 ± 4.017.30 ± 6.763.41 ± 3.512.69 ± 1.873.51 ± 3.548.87 ± 12.65
Day 424.40 ± 4.938.34 ± 12.375.73 ± 6.452.09 ± 1.314.32 ± 4.1910.41 ± 13.26
Day 562.43 ± 1.819.60 ± 11.804.90 ± 2.972.46 ± 1.476.19 ± 7.717.97 ± 12.87
Statistical analysis
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.3833
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.4909
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.2200
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.4183
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.4650
SecondarySerum Amyloid-A Levels
Time frame:
Day 1, 14, 28, 42, 56
Reported as:
Mean · Picogram per milliliter
Serum Amyloid-A Levels
Picogram per milliliterILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Day 126586201 ± 3978754633048188 ± 4586889922784245 ± 4717362013112923 ± 1365559432684269 ± 2435810634103493 ± 33363700
Day 1426708755 ± 5170351837392805 ± 4294002113930628 ± 917916115927358 ± 1710045838017589 ± 2766290655781761 ± 63622877
Day 2816191087 ± 1781843026521088 ± 2241713211795968 ± 574198618546404 ± 2665101740780444 ± 2919774255618175 ± 47529302
Day 4221215328 ± 2850589819716955 ± 1218077510203678 ± 887885319929741 ± 3244484535032152 ± 2756572660686782 ± 59133991
Day 569510659 ± 1163287927246194 ± 2370111417500314 ± 2139009113943320 ± 1458389935800358 ± 2568432049462769 ± 58393285
Statistical analysis
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.7051
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.1072
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.0020
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.0079
  • ILV-094 100 mg + 50 mg Subcutaneous vs ILV-094 200 mg + 100 mg Subcutaneous vs ILV-094 300 mg + 150 mg Intravenous vs ILV-094 600 mg + 300 mg Intravenous · ANCOVA · p = 0.0308
SecondaryPercent 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
Reported as:
Mean · Percent change
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Week 2, 4, 6, 8 and 12
Percent changeILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Week 213.1 ± 17.313.5 ± 18.12.57 ± 9.2914.0 ± 15.820.1 ± 14.911.3 ± 17.9
Week 411.4 ± 19.324.8 ± 34.06.36 ± 10.213.8 ± 16.732.6 ± 17.921.1 ± 20.3
Week 621.3 ± 21.619.3 ± 34.35.88 ± 16.030.3 ± 30.238.8 ± 21.425.8 ± 24.1
Week 827.3 ± 25.028.0 ± 34.68.71 ± 16.638.4 ± 38.639.4 ± 25.336.7 ± 39.1
Week 12———38.9 ± 41.538.3 ± 30.747.8 ± 38.4
SecondaryPercent 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
Reported as:
Mean · Percent change
Percent Change From Baseline in Target Lesion Score (TLS) at Week 2, 4, 6, 8 and 12
Percent changeILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Week 21.38 ± 1.760.75 ± 1.211.00 ± 1.601.00 ± 1.211.69 ± 1.891.38 ± 1.66
Week 40.92 ± 1.561.58 ± 2.391.00 ± 1.481.83 ± 1.953.50 ± 2.242.38 ± 1.94
Week 61.83 ± 2.211.30 ± 2.261.18 ± 1.782.50 ± 2.283.75 ± 2.562.92 ± 2.15
Week 82.00 ± 2.831.80 ± 2.041.10 ± 1.203.08 ± 2.684.17 ± 2.522.83 ± 2.48
Week 12———3.27 ± 3.473.40 ± 2.173.75 ± 2.60
SecondaryPercent 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
Reported as:
Mean · Percent change
Percent Change From Baseline in Physician Global Assessment Score at Week 2, 4, 6, 8 and 12
Percent changeILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Week 20.46 ± 0.780.33 ± 0.490.17 ± 0.390.55 ± 0.690.54 ± 0.520.23 ± 0.44
Week 40.25 ± 0.620.50 ± 0.670.18 ± 0.400.45 ± 0.521.08 ± 0.670.46 ± 0.66
Week 60.50 ± 0.670.50 ± 0.530.18 ± 0.400.73 ± 0.901.08 ± 0.900.75 ± 0.87
Week 80.82 ± 0.870.60 ± 0.520.20 ± 0.420.91 ± 0.941.25 ± 0.971.00 ± 0.95
Week 12———1.00 ± 0.821.10 ± 0.880.92 ± 0.90
Other pre-specifiedNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Drug Antibodies Response
ParticipantsILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Number of Participants With Positive Anti-Drug Antibodies Response000301

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ILV-094 100 mg + 50 mg Subcutaneous—0/13 (0%)3/13 (23.1%)
ILV-094 200 mg + 100 mg Subcutaneous—0/12 (0%)9/12 (75%)
Placebo Subcutaneous—0/13 (0%)7/13 (53.8%)
ILV-094 300 mg + 150 mg Intravenous—0/12 (0%)11/12 (91.7%)
ILV-094 600 mg + 300 mg Intravenous—2/13 (15.4%)9/13 (69.2%)
Placebo Intravenous—0/13 (0%)9/13 (69.2%)
Most frequent serious events
Most frequent serious events
EventILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Abdominal painGastrointestinal disorders0/130/120/130/121/130/13
Chest painGeneral disorders0/130/120/130/121/130/13
Most frequent other events
Showing 10 of 92
Most frequent other events
EventILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo Intravenous
Back painMusculoskeletal and connective tissue disorders0/133/120/131/120/130/13
PruritusSkin and subcutaneous tissue disorders0/130/120/132/123/130/13
DiarrhoeaGastrointestinal disorders0/132/120/131/121/130/13
NasopharyngitisInfections and infestations2/132/120/131/121/130/13
Blood triglycerides increasedInvestigations0/132/120/132/120/130/13
Pain in extremityMusculoskeletal and connective tissue disorders0/131/120/132/120/131/13
HeadacheNervous system disorders0/132/120/132/122/132/13
GlycosuriaRenal and urinary disorders0/132/120/130/120/130/13
GastroenteritisInfections and infestations0/130/120/130/121/132/13
CoughRespiratory, thoracic and mediastinal disorders0/130/120/131/122/130/13

Baseline characteristics

Safety analysis population included all randomized participants who received at least 1 dose of study medication.

Age, Continuous
Age, Continuous(years)ILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo IntravenousTotal
Mean38.54 ± 12.7345.92 ± 10.1544.46 ± 14.6648.42 ± 14.0247.69 ± 8.4942.00 ± 15.5544.43 ± 12.89
Sex: Female, Male
Sex: Female, Male(Participants)ILV-094 100 mg + 50 mg SubcutaneousILV-094 200 mg + 100 mg SubcutaneousPlacebo SubcutaneousILV-094 300 mg + 150 mg IntravenousILV-094 600 mg + 300 mg IntravenousPlacebo IntravenousTotal
Female0122229
Male13111110111167
08

Study locations

24 sites
  • David Stoll, MD
    Beverly Hills, California 90212, United States
  • Dermatology Research
    Santa Monica, California 90404, United States
  • Miami Research Associates
    South Miami, Florida 33143, United States
  • MRA Clinical Research
    South Miami, Florida 33143, United States
  • Hudson Dermatology
    Evansville, Indiana 47714, United States
  • Dawes Fretzin Clinical Research Group
    Indianapolis, Indiana 46256, United States
  • Dawes Fretzin Dermatology Group
    Indianapolis, Indiana 46256, United States
  • Hamzavi Dermatology
    Fort Gratiot, Michigan 48059, United States
  • Central Dermatology
    Saint Louis, Missouri 63117, United States
  • New York University Medical Center
    New York, New York 10016, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • Duke Clinical Reseach Unit
    Durham, North Carolina 27710, United States
  • The Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Altoona Center for Clinical Research
    Duncansville, Pennsylvania 16635-0909, United States
  • Baylor Research Institute
    Dallas, Texas 75246-1613, United States
  • Stratical Medical
    Edmonton, Alberta T5K 1X3, Canada
  • University of Alberta, Hospital Site Clinical Sciences Building
    Edmonton, Alberta T6G 2B7, Canada
  • The Northern Alberta Clinical Trials and Research Centre (NACTRC)
    Edmonton, Alberta T6G 2C8, Canada
  • Bio Pharma Services Inc
    Toronto, Ontario M9L 3A2, Canada
  • K. Papp Clinical Research
    Waterloo, Ontario N2J 1C4, Canada
  • Innovaderm Recherches Inc
    Montreal, Quebec H2K 4L5, Canada
  • Queen Mary Hospital
    Hong Kong, Hong Kong
  • FARMOVS Parexel (Pty) Ltd
    Bloemfontein, Free State 9301, South Africa
  • Parexel George
    George, Western Cape 6529, South Africa
09

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00563524
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Responsible party
Sponsor
First posted
Nov 26, 2007
Start date
Dec 20, 2007
Primary completion
Jun 14, 2010
Completion
Jun 14, 2010
Results posted
Aug 23, 2024
Last update
Aug 23, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Psoriasis →

Other studies from this sponsor

Wyeth is now a wholly owned subsidiary of Pfizer →

Start the discussion