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Study on the Effects of PF-07275315 and PF-07264660 for Adults with Moderate to Severe Atopic Dermatitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Moderate-Severe Atopic Dermatitis, a skin condition that causes red, itchy, and inflamed skin. The study will test two investigational treatments, known by their code names PF-07275315 and PF-07264660, both developed by Pfizer Inc. These treatments are biologic medications, which means they are made from proteins and other substances found in living organisms. The purpose of the study is to evaluate how effective and safe these treatments are compared to a placebo in adults with moderate to severe atopic dermatitis.

Participants in the study will be randomly assigned to receive either one of the investigational treatments or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are not biased. The study will last for several weeks, during which participants will have regular check-ups to monitor their skin condition and overall health. The main goal is to see if there is a significant improvement in the skin condition, measured by a tool called the Eczema Area and Severity Index (EASI), which assesses the extent and severity of eczema.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The researchers will also track any changes in vital signs, such as heart rate and blood pressure, as well as results from laboratory tests. The study aims to provide valuable information on whether these new treatments can offer a safe and effective option for people suffering from moderate to severe atopic dermatitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants are required to meet specific criteria, including being 18 years or older and having a clinical diagnosis of chronic atopic dermatitis for approximately 6 months prior to the start of the study.
Participants must have moderate to severe atopic dermatitis, defined by an affected body surface area of 10% or more, a visual assessment score of 3 or higher, and an Eczema Area and Severity Index (EASI) score of 16 or higher.
Step 2
Randomization and treatment
Participants are randomly assigned to receive either the study medications PF-07275315 and PF-07264660 or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.
The study aims to compare the effectiveness of the medications against a placebo by measuring improvements in the EASI score.
Step 3
Treatment duration
The treatment period lasts for 16 weeks. During this time, participants will receive the assigned treatment according to the study protocol.
The primary goal is to achieve a 75% improvement in the EASI score by the end of week 16.
Step 4
Monitoring and assessments
Throughout the study, participants will undergo regular assessments to monitor their condition and any changes in their EASI score.
Secondary goals include achieving a clear or almost clear visual assessment score and monitoring any side effects or changes in vital signs, heart activity, and laboratory tests.
Step 5
Completion of the study
At the end of the 16-week treatment period, participants will have a final assessment to evaluate the overall effectiveness of the treatment.
The study is expected to conclude by February 2026, with recruitment starting in July 2024.

Who can join the trial?

8 criteria

Participants must be aged 18 years or older.
Participants must have a clinical diagnosis of chronic atopic dermatitis for about 6 months before the start of the study. Atopic dermatitis is a skin condition that causes itchy and inflamed skin.
The diagnosis of atopic dermatitis must be confirmed using specific criteria known as the Hanifin and Rajka criteria.
Participants must have either an inadequate response to standard treatments for atopic dermatitis (excluding certain strong medications that suppress the immune system) for at least 4 weeks within the last 6 to 12 months, or a documented reason why these treatments are not suitable for them.
Participants must have moderate to severe atopic dermatitis, which means:
An affected Body Surface Area (BSA) of 10% or more. BSA is the percentage of the body covered by the skin condition.
A vIGA score of 3 or more. vIGA is a scale used to measure the severity of the skin condition.
An Eczema Area and Severity Index (EASI) score of 16 or more. EASI is a tool used to assess the extent and severity of eczema.

Who cannot join the trial?

7 criteria

Participants with any other skin condition that might interfere with the study results.
Individuals who have used certain medications that could affect the study within a specific time frame before the trial.
People with a history of severe allergic reactions to any of the study medications.
Participants with any significant medical condition that could make it unsafe for them to participate.
Individuals who are pregnant or breastfeeding.
People who have participated in another clinical trial recently.
Participants who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Provita Sp. z o.o.
Katowice, Poland
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Synexus Polska Sp. z o.o.
Poznan, Poland

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Investigated drugs

PF-07275315
is an investigational medication being studied for its potential to treat moderate to severe atopic dermatitis, a chronic skin condition characterized by inflamed, itchy skin. The medication is being tested to see if it can reduce the severity and area of eczema symptoms in patients.
PF-07264660
is another investigational medication included in the study, also aimed at treating moderate to severe atopic dermatitis. This medication is being evaluated for its effectiveness in improving the skin condition by reducing the symptoms and affected areas of eczema.

What is already known about the treatment

PF-07275315
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderate to severe atopic dermatitis. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication is to alleviate symptoms of atopic dermatitis, a chronic skin condition. The medication works by targeting specific pathways in the immune system to reduce inflammation and skin irritation. It is classified as an immunomodulatory agent.
PF-07264660
This medication is also administered orally and is in the clinical trial phase for treating moderate to severe atopic dermatitis. Like PF-07275315, it is not yet established in medical literature due to its ongoing evaluation. It aims to treat atopic dermatitis by modulating immune responses to decrease inflammation and improve skin condition. It falls under the category of immunomodulatory drugs.

Investigated diseases

Atopic Dermatitis – Atopic dermatitis, commonly known as eczema, is a chronic skin condition characterized by inflamed, itchy, and red patches of skin. It often begins in childhood but can occur at any age. The skin may become dry, cracked, and prone to infections due to frequent scratching. Flare-ups can be triggered by environmental factors, stress, or allergens. The condition tends to wax and wane, with periods of remission and exacerbation. It is associated with other allergic conditions such as asthma and hay fever.