NCT02780167已完成2 期
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER, DOSE-RANGING, STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-04965842 IN SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS
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
- 269
- 试验地点
- 64
- 主要终点
- Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
研究概览
简要总结
Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease severity in patients with moderate to severe AD as measured by the Investigator's Global Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support further clinical development of PF 04965842.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- •Must have the following atopic dermatitis criteria:
- •Have a clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year prior to Day 1 and has confirmed atopic dermatitis (Hanifin and Rajka criteria of AD refer to Appendix 2) at the Screening visit.
- •Have inadequate response to treatment with topical medications given for at least 4 weeks, or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks) within 12 months of the first dose of study drug.
- •Moderate to severe AD (affected BSA >=10 %, IGA >=3, and EASI >=12 at the screening and baseline visits).
排除标准
- •History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- •Infected with hepatitis B or hepatitis C viruses.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- •Have received any of the following treatment regiments specified in the timeframes outlined below:
- •Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.
- •Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.
- •Within 1 week of first dose of study drug: Topical treatments that could affect atopic dermatitis; Herbal medications with unknown properties or known beneficial effects for AD.
研究组 & 干预措施
Cohort 1
Experimental
10 mg of PF-04965842 QD
干预措施: PF-04965842 (Drug)
Cohort 2
Experimental
30 mg of PF-04965842 QD
干预措施: PF-04965842 (Drug)
Cohort 3
Experimental
100 mg of PF-04965842 QD
干预措施: PF-04965842 (Drug)
Cohort 4
Experimental
200 mg of PF-04965842 QD
干预措施: PF-04965842 (Drug)
Cohort 5
Placebo Comparator
placebo QD
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12
时间窗: Baseline and Week 12
The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).
次要结局
- Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12(Baseline and Week 12)
- Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113)
- Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12(Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.)
- Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points(All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Change From Baseline in Affected BSA at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16)
- Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.(Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16)
- Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113)
- Time to Achieving >=3 Points Improvement in NRS(Baseline till Week 16)
- Time to Achieving >=4 Points Improvement in NRS(Baseline till Week 16)
- Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113)
- Change From Baseline in Pruritus NRS Score at All Scheduled Time Points(Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113)
- Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points(All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points(All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Number of Participants With Treatment-emergent Adverse Events (AEs)(Baseline till Week 16)
- Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)(Baseline up to Week 16)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16)
- Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16)
- Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percent Change From Baseline in SCORAD at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16)
- Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points(Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16)
研究者
研究点 (64)
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