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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Synexus Polska Sp. z o.o. Poznan Poland
Pratia S.A. Skorzewo Poland
BAG Dres. med. Quist PartG Mainz Germany
Zdybski Med. Sp. z o.o. Ostrowiec Swietokrzyski Poland
Mxivvryyyxe Cyjoydw Fzm Mlhjpff Spisceh &idju Scuhdlac Gcxx Magdeburg Germany
Tanhikuyupt uab Suivisfgtli Bugprcbr Gdtr Bad Bentheim Germany
Paqdatd Sof z ojca Katowice Poland
Nxovx Twcaihhew – Ccgkewz Bferk Krkbcdoqqrd Poznan Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
31.07.2024
Poland Poland
Recruiting
31.07.2024

Trial locations

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.

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.

Trial ID:
2023-505218-68-00
Protocol code:
C4531002
NCT ID:
NCT05995964
Trial Phase:
Therapeutic exploratory (Phase II)

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