JPRN-jRCT2031220347已完成2 期
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
Kawai Norisuke0 个研究点目标入组 240 人开始时间: 2022年9月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Inclusion Criteria for AD population:
- •*Diagnosis of Atopic Dermatitis (AD) for at least 3 months
- •*Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate)
- •*AD covering 5% and up to 40% of Body Surface Area (BSA)
- •*A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of >=2
- •Inclusion Criteria for Plaque Psoriasis
- •*Diagnosis of Plaque Psoriasis (PsO) for at least 6 months
- •*Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe)
- •*PsO covering 2% to 20% (inclusive) of BSA
排除标准
- •Exclusion Criteria:
- •*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
研究者
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