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A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema

RecruitingPhase 2Ages 18 Years - 64 YearsAllPfizer
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In plain words

What the trial is, and whether it could suit you

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 par

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • PF-08049820
  • Placebo
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Where

42 sites
Mayo Clinic Hospital
Phoenix, United States
Mayo Clinic Specialty Building
Phoenix, United States
Mayo Clinic
Scottsdale, United States
Marvel Clinical Research
Huntington Beach, United States
Metropolis Dermatology - DTLA
Los Angeles, United States
Northridge Clinical Trials
Northridge, United States
Clinical Science Institute
Santa Monica, United States
Gsi Clinical Research
Margate, United States

โ€ฆand 34 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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