跳至主要内容
临床试验/NCT03895372
NCT03895372已完成2 期

A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Pfizer43 个研究点 分布在 4 个国家目标入组 179 人开始时间: 2019年6月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Pfizer
入组人数
179
试验地点
43
主要终点
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

研究概览

简要总结

This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female between the ages of 18 and 75 years.
  • Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
  • Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
  • Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

排除标准

  • Have non-plaque forms of psoriasis.
  • Drug-induced psoriasis.
  • Current active infection.
  • Infected with Mycobacterium tuberculosis (TB).
  • Have any history of malignancies.
  • Require treatment with prohibited concomitant medications(s).
  • Positive for hepatitis B or C, or human immunodeficiency virus (HIV).

研究组 & 干预措施

PF-06826647 Drug Dose Level 1

Experimental

Delivered orally for 16 weeks during the Investigational Treatment Period

干预措施: PF-06826647 or Placebo (Drug)

PF-06826647 Placebo

Experimental

Delivered orally for 16 weeks during the Investigational Treatment Period

干预措施: PF-06826647 or Placebo (Drug)

PF-06826647 Drug Dose Level 2

Experimental

Delivered orally for 16 weeks during the Investigational Treatment Period

干预措施: PF-06826647 or Placebo (Drug)

PF-06826647 Drug Dose Level 3

Experimental

Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.

干预措施: PF-06826647 or Placebo (Drug)

PF-06826647 Drug Dose Level 3

Experimental

Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.

干预措施: PF-06826647 (Drug)

PF-06826647 Drug Dose Level 4

Experimental

Delivered orally for 16 weeks then for 24 weeks in Extension Period.

干预措施: PF-06826647 or Placebo (Drug)

PF-06826647 Drug Dose Level 4

Experimental

Delivered orally for 16 weeks then for 24 weeks in Extension Period.

干预措施: PF-06826647 (Drug)

结局指标

主要结局

Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was 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. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 milliseconds (msec) and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30 change =\<60 or \>60 msec from baseline.

Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) \< 50 millimeter of mercury (mmHg), sitting diastolic BP change \>= 20 mmHg increase, sitting diastolic BP change \>= 20 mmHg decrease, sitting systolic BP \< 90 mmHg, sitting systolic BP change \>= 30 mmHg increase, and sitting systolic BP change \>= 30 mmHg decrease.

Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.

Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.

Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period

时间窗: Baseline up to Week 16

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.

Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was 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. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period

时间窗: From Week 16 to Week 40

Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.

次要结局

  • Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16.)
  • Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)
  • Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period(Baseline up to Week 16)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (43)

Loading locations...

相似试验