The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are 18 years of age or more; 2. Were confirmed to have AD at least 6 months ago; 3. Do not have a suitable prescribed medicine for AD; 4. Are considered by their doctors to have moderate to severe AD. Eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12, and have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. Participants will have blood and urine tests and must answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to participants receiving placebo. This will help to understand if PF-08049820 is safe and effective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Tablet
Tablet
Clinical Science Institute
Santa Monica, California, United States
Gsi Clinical Research
Margate, Florida, United States
Skin Research of South Florida
Miami, Florida, United States
Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States
Hattori Dermatology Clinic
Takasaki, Gunma, Japan
Kosugi Dermatology Clinic
Kawasaki-shi, Kanagawa, Japan
Queen's Square Medical Facilities
Yokohama, Kanagawa, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12
Time frame: Week 12
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points
Time frame: Day 1 through Week 16
Percent change from baseline in EASI total score at scheduled time points other than Week 12
Time frame: Day 1 through Week 16
Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of >2 points at scheduled time points
Time frame: Day 1 through Week 16
Response based on achieving ≥4 points of reduction from baseline in weekly averages of Peak Pruritus-Numerical Rating Scale (PP-NRS4) at scheduled time points
Time frame: Day 1 through Week 16
Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), and clinically significant changes in laboratory tests, vital signs and ECGs
Time frame: Day 1 through Week 16
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