A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 104
- 试验地点
- 28
- 主要终点
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
研究概览
简要总结
This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
- •Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
排除标准
- •Presence of skin comorbidities that would interfere with study assessment or response to treatment.
- •Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- •Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
研究组 & 干预措施
atopic dermatitis - PF-07038124 ointment
干预措施: PF-07038124 ointment (Drug)
atopic dermatitis - vehicle ointment
干预措施: Vehicle ointment (Drug)
plaque psoriasis - PF-07038124 ointment
干预措施: PF-07038124 ointment (Drug)
plaque psoriasis - vehicle ointment
干预措施: Vehicle ointment (Drug)
结局指标
主要结局
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
时间窗: Baseline, Week 6
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
时间窗: Baseline, Week 6
EASI evaluated severity of participants' 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 \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in 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
- Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS(Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS(Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Number of Participants With Laboratory Test Abnormalities(Day 1 through Week 6)
- Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP(Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose))
- Percentage of AD Participants Achieving Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6(Baseline, Week 6)
- Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)(Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS(Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS(Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6(Baseline, Weeks 1, 2, 4 and 6)
- Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants(Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS(Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose))
- Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS(Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria(Day 1 through Week 6)
- Percentage of Psoriasis Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6(Baseline, Week 6)
- Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS(Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose))
- Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Day 1 through Week 6)
- Number of Participants With Vital Signs Data Meeting Pre-defined Criteria(Day 1 through Week 6)