A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 263
- 试验地点
- 36
- 主要终点
- Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only
研究概览
简要总结
The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.
This study is seeking participants who
If they have Atopic Dermatitis (AD):
- Have a diagnosis for at least 3 months
- Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA)
- Have percent Body Surface Area (%BSA) covering 5% up to 40%
- A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period
If they have plaque psoriasis (PsO):
- Have a diagnosis for at least 6 months
- Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA)
- Have percent Body Surface Area (%BSA) covering 2% up to 20%
All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group.
PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective.
Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Presence of skin comorbidities that would interfere with study assessment or response to treatment
- •Psychiatric condition including recent or active suicidal ideation or behavior
- •Current or recent history of severe, progressive, or uncontrolled disease
- •A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
- •Recent, significant trauma or major surgery
- •History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
- •History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
- •Use of any prohibited concomitant medication(s)
- •Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
- •Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old)
- •Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
- •Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec
- •A recent history of alcohol or substance abuse
研究组 & 干预措施
Atopic Dermatitis PF-07038124 0.01% ointment
Atopic Dermatitis
干预措施: PF-07038124 ointment 0.01% (Drug)
Atopic Dermatitis Vehicle ointment
Atopic Dermatitis
干预措施: Vehicle ointment (Drug)
Atopic Dermatitis PF-07038124 0.03% ointment
Atopic Dermatitis
干预措施: PF-07038124 ointment 0.03% (Drug)
Plaque Psoriasis PF-07038124 0.01% ointment
Plaque Psoriasis
干预措施: PF-07038124 ointment 0.01% (Drug)
Plaque Psoriasis PF-07038124 0.03% ointment
Plaque Psoriasis
干预措施: PF-07038124 ointment 0.03% (Drug)
Plaque Psoriasis PF-07038124 0.06% ointment
Plaque Psoriasis
干预措施: PF-07038124 ointment 0.06% (Drug)
Plaque Psoriasis Vehicle ointment
Plaque Psoriasis
干预措施: Vehicle ointment (Drug)
结局指标
主要结局
Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only
时间窗: Baseline, Week 12
IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method.
Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only
时间窗: Baseline, Week 12
The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of \>=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method.
次要结局
- Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only(Baseline, Week 1, 2, 4, 6, 8, and 10)
- Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only(Baseline, Week 1, 2, 4, 6, 8, and 10)
- Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only(Week 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only(Week 1, 2, 4, 6, 8, 10 and 12)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only(Week 1, 2, 4, 6, 8, 10 and 12)
- Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis(Baseline, Week 1, 2, 4, 6, 8, 10 and 12)
- Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks))
- Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks))
- Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment (Day 1) up to Week 12)
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment (Day 1) up to Week 12)
- Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment (Day 1) up to Week 12)
- Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis(From start of study treatment (Day 1) up to Week 12)