A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 292
- 试验地点
- 73
- 主要终点
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
研究概览
简要总结
This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Atopic Dermatitis for at least 3 months
- •Investigator's Global Assessment (IGA) Score of 2 or 3
- •Eczema Area Severity Index (EASI) score of 3-21
- •Body Surface Area (BSA) of 2-20%
- •Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more
排除标准
- •Other forms of dermatological diseases (other than atopic dermatitis)
- •Fitzpatrick skin type score greater than 5
- •Clinically significant abnormal ECG, vital signs, and laboratory values
- •Infection with HBV, HCV, herpes zoster or tuberculosis
研究组 & 干预措施
PF-06700841 0.1% cream QD
PF-06700841 0.1% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 0.3% cream QD
PF-06700841 0.3% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 1% cream QD
PF-06700841 1% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 3% cream QD
PF-06700841 3% cream applied once daily (QD)
干预措施: PF-06700841 (Drug)
PF-06700841 0.3% cream BID
PF-06700841 0.3% cream applied twice daily (BID)
干预措施: PF-06700841 (Drug)
PF-06700841 1% cream BID
PF-06700841 1% cream applied twice daily (BID)
干预措施: PF-06700841 (Drug)
Vehicle cream QD
Vehicle cream applied once daily (QD)
干预措施: Vehicle (Placebo) (Drug)
Vehicle cream BID
Vehicle cream applied twice daily (BID)
干预措施: Vehicle (Placebo) (Drug)
结局指标
主要结局
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
时间窗: Baseline, Week 6
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\>0 to \<10%), 2 (10 to \<30%), 3 (30 to \<50%), 4 (50 to \<70%), 5 (70 to \<90%) and 6 (90 to 100%). Total EASI score =0.1\*Ah\*(Eh+Ih+Exh+Lh) + 0.2\*Au\*(Eu+Iu+ExU+Lu) + 0.3\*At\*(Et+It+Ext+Lt) + 0.4\*Al\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
次要结局
- Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation(Baseline, Week 6)
- Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation(Baseline, Weeks 1, 2, 3, 4 and 6)
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation(Baseline, Week 6)
- Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation(Baseline, Weeks 1, 2, 3, 4 and 6)
- Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation(Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11))
- Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings(Baseline up to Week 6)
- Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Number of Participants With Laboratory Abnormalities(Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11))
- Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6(Baseline, Weeks 2 and 6)
- Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6(Baseline, Weeks 2 and 6)
- Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6(Baseline, Weeks 2 and 6)
- Number of Participants With Pre-defined Criteria For Vital Signs(Baseline up to Week 6)
- Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Lipids Profile Values at Week 6(Baseline, Week 6)
- Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6(Baseline, Week 6)
- Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Number of Participants With Each Severity Grade in Local Tolerability Assessments(Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11))
- Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit(Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71))
- Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6(Baseline, Weeks 2 and 6)
- Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6(Baseline, Weeks 2 and 6)