A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are 18 to 64 years of age
Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
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;
Disqualifiers
Have an infection that requires treatment
Have other skin conditions other than AD
Have severe uncontrolled asthma
Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit
Trial design
Design model
Parallel
Treatments tested in this trial
PF-08049820
DrugTablet
Placebo
DrugTablet
Treatment groups
165 Participants
are divided into 4 treatment groupsGroup A: Arm 2Experimental treatment 1 intervention
Group B: Arm 3Experimental treatment 1 intervention
Group C: Arm 1Experimental treatment 1 intervention
Group D: Arm 4Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12
Time frame
Week 12Secondary outcomes
1
Response based on achieving EASI75 (≥75% improvement from baseline) at scheduled time points
Time frame
Day 1 through Week 162
Percent change from baseline in EASI total score at scheduled time points other than Week 12
Time frame
Day 1 through Week 163
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 164
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 Source ClinicalTrials.gov