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临床试验/NCT03469336
NCT03469336已完成1 期

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS

Pfizer2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年4月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Pfizer
入组人数
18
试验地点
2
主要终点
Change From Baseline in Psoriatic Skin Infiltrate Thickness

研究概览

简要总结

The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.

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

  • •Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas
  • •Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

排除标准

  • •History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
  • •Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
  • •Treatment with any biologics within 3 months prior to Day 1 of the study and during the study

研究组 & 干预措施

All subjects

Other

All subjects will receive all six interventions/treatments applied to six different treatment fields.

干预措施: Vehicle (Other)

All subjects

Other

All subjects will receive all six interventions/treatments applied to six different treatment fields.

干预措施: Calcipotriene/calcipotriol (Drug)

All subjects

Other

All subjects will receive all six interventions/treatments applied to six different treatment fields.

干预措施: Betamethasone (Drug)

All subjects

Other

All subjects will receive all six interventions/treatments applied to six different treatment fields.

干预措施: PF-06763809 (Drug)

结局指标

主要结局

Change From Baseline in Psoriatic Skin Infiltrate Thickness

时间窗: Baseline, Days 7, 13 and 19

Baseline was defined to be the measurement on Day 1. MMRM analysis of changes in psoriatic skin in psoriatic skin infiltrate thickness/echo poor band (EPB) in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically for 18 consecutive days as compared to the vehicle control. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.

Number of Participants With Treatment-emergent Adverse Events (AEs)

时间窗: Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of investigational product.

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

时间窗: Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Hematology evaluation included: hemoglobin (HGB) (gram per decilitre=g/dL), hematocrit, erythrocytes (Ery.), Ery. Mean Corpuscular Volume, Ery. Mean Corpuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration (picograms per cell=pg/cell), platelets, leukocytes, lymphocytes, and neutrophils. Clinical chemistry evaluation included: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, creatine kinase, and glucose. Urinalysis evaluation included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, and leukocyte esterase. LLN=lower limit of normal, ULN=upper limit of normal.

Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria

时间窗: Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. ECG categorical summarization criteria: 1) PR interval (Value\>=300 milliseconds \[msec\], %Change \[Chg\]\>=25/50%); 2) QRS interval (Value\>=140 msec, \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of \>=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to \<480 msec, 480 to \<500 msec, \>=500 msec; a change from baseline of 30 to \<60 msec or \>=60 msec. The corrected QT interval by Fredericia=QTcF Interval.

Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria

时间窗: Day 1 to Day 49

Baseline was defined to be the measurement on Day 1. Vital Signs including diastolic blood pressure (DBP), pulse rate, and systolic blood pressure (SBP) were measured.

次要结局

  • Area Under the Curve of the Psoriatic Skin Infiltrate Thickness(Day 1 to Day 19)
  • Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Calcipotriene/Calcipotriol Solution.(Baseline, Days 7, 13 and 19)
  • Change From Baseline in Skin Infiltrate Thickness in Response to PF-06763809 Compared to Betamethasone Solution.(Baseline, Days 7, 13 and 19)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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