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| ID | Type | Description | Link |
|---|---|---|---|
| B1991002 | Other Identifier | Alias Study Number |
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See termination reason in detailed description.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILV-095 | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILV-095 300 mg in a 4 to 1 ratio | Drug | Single dose of ILV-095 300 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 2 |
| 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. | Baseline, Week 4 |
| Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Research | Miami Gardens | Florida | 33169 | United States | ||
| Miami Research Associates, Inc. |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ILV-095 100 mg | Participants received single dose of ILV-095 100 mg subcutaneously on Day 1 and were followed up to Week 16. |
| FG001 | ILV-095 300 mg | Participants received single dose of ILV-095 300 mg subcutaneously on Day 1 and were followed up to Week 16. |
| FG002 | Placebo | Participants received single dose of placebo matching to ILV-095 subcutaneously on Day 1 and were followed up to Week 16. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population included all randomly assigned participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | ILV-095 100 mg | Participants received single dose of ILV-095 100 mg subcutaneously on Day 1 and were followed up to Week 16. |
| BG001 | ILV-095 300 mg | Participants received single dose of ILV-095 300 mg subcutaneously on Day 1 and were followed up to Week 16. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 2 |
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The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ILV-095 100 mg | Participants received single dose of ILV-095 100 mg subcutaneously on Day 1 and were followed up to Week 16. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
The study was early terminated based on the outcome of interim analysis and not due to any safety reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ILV-095 300 mg in a 4 to 1 ratio |
| Drug |
Single dose of Placebo |
|
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. |
| Baseline, Week 6 |
| 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. | Baseline, Week 8 |
| Pre-treatment (Day -1), Week 2, 4, 6, 8 |
| 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. | Pre-treatment (Day -1), Week 2, 4, 6, 8 |
| 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). | Baseline (Day 1) up to Week 16 |
| 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. | Baseline (Day 1) up to Week 16 |
| 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. | Baseline (Day 1) up to Week 16 |
| 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 | t1/2 was the time measured for the serum concentration of ILV-095 to decrease by one half. | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
| 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. | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
| 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). | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
| 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). | 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 (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. | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
| 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. | Baseline, Day 14, 56,112 |
| 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. | Baseline, Day 14, 56,112 |
| 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. | Baseline, Day 14, 56,112 |
| 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. | Baseline, Day 14, 56,112 |
| 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. | Baseline up to Week 16 |
| 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. | Baseline up to Week 16 |
| South Miami |
| Florida |
| 33143 |
| United States |
| MRA Clinical Research | South Miami | Florida | 33143 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29651 | United States |
| NewLab Clinical Research Inc | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Withdrawal by Subject |
|
| BG002 | Placebo | Participants received single dose of placebo matching to ILV-095 subcutaneously on Day 1 and were followed up to Week 16. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 4 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 6 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 8 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment (Day -1), Week 2, 4, 6, 8 |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-treatment (Day -1), Week 2, 4, 6, 8 |
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| 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). | Safety population included all randomly assigned participants who took at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 16 |
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| 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. | Safety population included all randomly assigned participants who took at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 16 |
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| 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. | Safety population included all randomly assigned participants who took at least 1 dose of study medication. | Posted | Number | participants | Baseline (Day 1) up to Week 16 |
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| Other Pre-specified | Maximum Observed Serum Concentration (Cmax) of ILV-095 | 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. | Posted | Geometric Mean | Standard Deviation | microgram per milliliter (mcg/mL) | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| Other Pre-specified | Time to Reach Maximum Observed Serum Concentration (Tmax) of ILV-095 | 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. | Posted | Median | Full Range | days | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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. | 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. | Posted | Mean | Standard Deviation | days | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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. | 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. | Posted | Geometric Mean | Standard Deviation | microgram*hour per milliliter | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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). | 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. | Posted | Geometric Mean | Standard Deviation | microgram*hour per milliliter | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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). | 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. | Posted | Geometric Mean | Standard Deviation | liter per hour (L/hr) | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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. | 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. | Posted | Geometric Mean | Standard Deviation | liter | Pre-dose, 2, 4, 8, 24, 48, 120, 216, 312, 480, 648, 984, 1320, 1656, 1992, 2328, 2664 hours post-dose |
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| 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. | 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. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline, Day 14, 56,112 |
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| 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. | 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. | Posted | Mean | Standard Deviation | nanogram per liter (ng/L) | Baseline, Day 14, 56,112 |
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| 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. | 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. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline, Day 14, 56,112 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Day 14, 56,112 |
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| 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. | Safety population included all randomly assigned participants who took at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Week 16 |
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| 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. | Safety population included all randomly assigned participants who took at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Week 16 |
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| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | ILV-095 300 mg | Participants received single dose of ILV-095 300 mg subcutaneously on Day 1 and were followed up to Week 16. | 1 | 30 | 22 | 30 |
| EG002 | Placebo | Participants received single dose of placebo matching to ILV-095 subcutaneously on Day 1 and were followed up to Week 16. | 0 | 8 | 7 | 8 |
| Dry Eye | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Mydriasis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Parotid Gland Inflammation | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Temperature Intolerance | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Fungal Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Arthropod Sting | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Alanine Aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Aspartate Aminotransferase increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| C-Reactive Protein Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Impatience | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Tension | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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