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

Pfizer Inc.0 个研究点目标入组 280 人开始时间: 2019年5月27日最近更新: 2020年10月13日

研究概览

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•1. Female and Male participants between the ages of 18 and 75 years at the start of the study
•1.a. Males participants between the ages 12 and 75, after 1st IRC review of unblinded data.
•2. Have a clinical diagnosis of atopic dermatitis for at least 3 months
•3. Have an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate)
•4. Have an Eczema Area and Severity Index (EASI) total score of greater than or equal to 3 to less than or equal to 21
•5. Have Peak Pruritus - Numerical Rating Scale (PP-NRS) of Grade greater than or equal to 2, at Day 1.
•See section 5.1 of the Protocol for a full list of Inclusion Criteria
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 235
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Other dermatological diseases (psoriasis) and infections that would interfere with evaluation of atopic dermatitis or response to treatment
•2. Any history or recent psychiatric condition including recent or active suicidal ideation or behaviour
•3. A history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster
•4. A history of skin infection requiring hospitalization, parenteral antimicrobial or antifungals therapy
•5. Infected with Mycobacterium tuberculosis (TB)
•6. Infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
•See section 5.2 of the Protocol for a full list of Exclusion Criteria

发起方