A SINGLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND CLINICAL ACTIVITY OF ILV-095 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH PSORIASIS.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 39
- 试验地点
- 9
- 主要终点
- Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sexually active men or women must agree to use a medically acceptable form of contraception during the study and continue it for 16 weeks after investigational product administration.
- •Negative urine pregnancy test result for all women.
- •Body mass index (BMI) >=18 kg/m2 and body weight >=50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI = weight (kg)/(height [m]).
- •Must meet the following criteria for disease activity, at screening and/or at study entry (subjects who washout from prior therapy may not meet this level of disease activity at screening but must before being entered into the study).
- •Must have stable moderate to severe chronic plaque psoriasis covering >=15% of body surface area and be a candidate for systemic therapy or phototherapy.
- •Psoriasis Area Severity Index (PASI) score of >
- •Physician Global Assessment (PGA) of psoriasis score >=
- •Target lesion score >=6 based on the physician rating of selected sites for erythema, plaque elevation and scaling, with a minimum of 2 on the plaque elevation score. A-12-point score will be used with a 1-4 scale for each domain. Target lesions should not be on the scalp, axillae, face, or groin.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Evidence of unstable clinically significant disease (eg, unstable cardiovascular, renal, respiratory, or psychiatric disease or any serious disorder that currently requires physician care).
- •Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day
- •Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- •Presence of guttate, erythrodermic, or pustular psoriasis.
- •Active severe infections within 4 weeks before study day
- •Systemic malignancy within the past 5 years including melanoma. Treated skin cancer (basal cell carcinoma or squamous cell carcinoma) is excluded.
- •Evidence of latent tuberculosis by purified protein derivative (PPD) screening. PPD screening should be performed according to local standards using the tuberculin skin test (TST). Any result >5mm is considered positive. Prior Bacillus Calmette-Guerin (BCG) should not be taken into account when interpreting a TST result. TST must be performed during the screening period unless one has been performed within the previous 3 months and the results are available.
研究组 & 干预措施
ILV-095
干预措施: ILV-095 300 mg in a 4 to 1 ratio (Drug)
placebo
干预措施: ILV-095 300 mg in a 4 to 1 ratio (Drug)
结局指标
主要结局
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 2
时间窗: Baseline, Week 2
PASI score: combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72(maximal disease),with higher scores representing greater severity of psoriasis.Body divided into 4 sections(head and neck \[h\],arms \[u\],trunk \[t\],legs \[l\]);each area scored by itself and scores combined for final PASI score.For each section,percent body surface area(A) of skin involved was estimated:0 (no involvement) to 6 (90 to 100 percent involvement),severity estimated by clinical signs:erythema(E),infiltration(I),scaling(S);5 point scale:0(no involvement) to 4(very marked involvement).Final PASI score = 0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl),where head:0.1;upper limbs:0.2;trunk:0.3;lower limbs:0.4. Percentage of participants with at least 50 percent(%) improvement in total PASI score at Week 2 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 6
时间窗: Baseline, Week 6
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\],trunk \[t\],legs \[l\]);each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(I),scaling(S);5 point scale:0(no involvement) to 4(very marked involvement).Final PASI score = 0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl),where head:0.1;upper limbs:0.2;trunk:0.3;lower limbs:0.4. Percentage of participants with at least 50% improvement in total PASI score at Week 6 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 4
时间窗: Baseline, Week 4
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\],trunk \[t\],legs \[l\]);each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(I),scaling(S);5 point scale:0(no involvement) to 4(very marked involvement).Final PASI score = 0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl),where head:0.1;upper limbs:0.2;trunk:0.3;lower limbs:0.4. Percentage of participants with at least 50% improvement in total PASI score at Week 4 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
Percentage of Participants With 50 Percent Improvement From Baseline in Total Psoriasis Area Severity Index (PASI) Score at Week 8
时间窗: Baseline, Week 8
PASI score: combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72(maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\],trunk \[t\],legs \[l\]);each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90 to 100 percent involvement),severity estimated by clinical signs: erythema(E),infiltration(I),scaling(S);5 point scale:0(no involvement) to 4(very marked involvement).Final PASI score = 0.1Ah(Eh + Ih + Sh) + 0.2Au(Eu + Iu + Su) + 0.3At(Et + It + St) + 0.4Al(El + Il + Sl),where head:0.1;upper limbs:0.2;trunk:0.3;lower limbs:0.4. Percentage of participants with at least 50% improvement in total PASI score at Week 8 relative to baseline total PASI score was reported and 95% confidence interval was calculated using Clopper-Pearson (exact) method.
次要结局
未报告次要终点