jRCT2031250615
Not yet recruiting
Not Applicable
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema)
Not provided0 sites200 target enrollmentStarted: TBD
Conditions*Atopic Dermatitis
*Eczema, Atopic
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Participants must meet the following criteria:
- •1.Are 18 years of age or older
- •2.Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
- •3.Have moderate to severe AD as defined by the following at screening and baseline visits:
- •Affected body surface area (BSA) greater than or equal to 10% and up to 60%;
- •Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;
- •Eczema Area and Severity Index (EASI) greater than or equal to 16;
- •Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit
- •4.Do not have a suitable prescribed medicine for AD.
- •5.Body Mass Index (BMI) of 17.5 to 40 kg/m2 and a total body weight greater than 45 kg (100 lbs)
Exclusion Criteria
- •Participants must not meet the following criteria:
- •1.Have an infection that requires treatment
- •2.Have other skin conditions other than AD
- •3.Have severe uncontrolled asthma
- •4.Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit
Investigators
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