A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
NCT ID: NCT07216027
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-11-26
2027-08-23
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Tablets taken by mouth daily for 12 weeks
PF-08049820
Tablet
Arm 2
Tablets taken by mouth daily for 12 weeks
PF-08049820
Tablet
Arm 3
Tablets taken by mouth daily for 12 weeks
PF-08049820
Tablet
Arm 4
Tablets taken by mouth daily for 12 weeks
Placebo
Tablet
Arm 5 (Optional)
Tablets taken by mouth daily for 12 weeks
PF-08049820
Tablet
Arm 6 (Optional)
Tablets taken by mouth daily for 12 weeks
Placebo
Tablet
Interventions
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PF-08049820
Tablet
Placebo
Tablet
Eligibility Criteria
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Inclusion 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;
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 17.5 to 40 kg/m2 and a total body weight greater than 45 kg (100 lbs)
Exclusion 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2025-522965-31-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C6231002
Identifier Type: -
Identifier Source: org_study_id