Atopic Dermatitis, Eczema, Atopic
Conditions
Keywords
Eczema, Atopic Dermatitis
Brief summary
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 to 64 years of age; 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. The study has two stages (Stage 1 and Stage 2). In both stages, 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. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to 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 those receiving placebo. This will help to understand if PF-08049820 is safe and effective.
Interventions
DRUGPF-08049820
Tablet
DRUGPlacebo
Tablet
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet the following criteria: 1. Are 18 to 64 years of age 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; AND -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 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points | Day 1 through Week 16 |
| Percent change from baseline in EASI total score at scheduled time points other than Week 12 | 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 | 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 | 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 | Day 1 through Week 16 |
| Change from baseline in biomarker at scheduled time points | Day 1 through Week 16 |
Countries
Canada, China, Japan, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed