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New treatment option for Atopic Dermatitis
Official title A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
ClinicalTrials.gov ID: NCT07216027
What this study is testing
What is PF-08049820?
PF-08049820 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atopic dermatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet the following criteria:
- Are 18 years of age or older
- Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
- 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%;
You likely can't join if
- Participants must not meet the following criteria:
- 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
See the full eligibility criteria
- Participants must meet the following criteria:
- Are 18 years of age or older
- Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs
- 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...
- Do not have a suitable prescribed medicine for AD.
- Body Mass Index (BMI) of 17.5 to 40 kg/m2 and a total body weight greater than 45 kg (100 lbs)
- Participants must not meet the following criteria:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Northridge, California, United States
- Santa Monica, California, United States
- Margate, Florida, United States
- Miami, Florida, United States
- Takasaki, Gunma, Japan
- Kawasaki-shi, Kanagawa, Japan
- Yokohama, Kanagawa, Japan
- Sakai, Osaka, Japan
- Chuo-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Northridge, California, United States; Santa Monica, California, United States; Margate, Florida, United States; Miami, Florida, United States; Takasaki, Gunma, Japan; Kawasaki-shi, Kanagawa, Japan and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.