NCT05732454

Introducing a clinical trial for people with moderate-to-severe eczema (atopic dermatitis)

Atopic dermatitis (AD), the most common form of eczema, causes itchy, dry, cracked, and red skin. It is among the most common dermatological conditions worldwide.

This study is evaluating an oral, steroid-free investigational medication to see if it may safely and effectively reduce symptoms of AD.

The study medication is thought to work by stopping your immune system from creating unnecessary inflammation in your skin. This reduction in inflammation is thought to reduce the itchiness and pain associated with AD.

Card Summary Component

Who may participate

Taking part in a clinical study is an important decision. Thank you for your interest in this clinical research study.

This clinical study may be an option for you if:

  • You are between 18 and 80 years old
  • You have moderate-to-severe chronic atopic dermatitis (eczema)
  • Your atopic dermatitis (eczema) was diagnosed at least 1 year ago

There are other eligibility requirements. A final decision on whether this clinical research study might be suitable for you will be made after you have completed the online and phone questionnaire and you have spoken with the research study staff who will explain the benefits and risks of participation in this clinical research study.

Condition

Atopic dermatitis (eczema)

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Age

18 to 80 years old

The age a person must be to participate in a clinical trial.

Sex

Male or Female

The sex of people who may participate in a clinical trial. Sex is a person’s classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender.

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.

Get started — See if you may qualify

A first step as you consider this study is to answer a 5-minute questionnaire about your health and medical history online. If your answers show the study might be a good fit for you, you may choose to be referred to a clinical research site that you select.

You will then be asked to provide your contact information for a member of the research study staff to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.

Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the clinical research site that you select. Pfizer study team members and our partners will have access to reports containing collected data that will not be linked back to you.

Card Summary Component

What to expect

If you are a good fit for the study, you will be randomly assigned to receive either the oral investigational medication or a placebo for 16 weeks. This is called a double blind period.

A placebo looks like the oral investigational medication but does not contain any active ingredients.

Depending on how your body responds to the 16-week double blind study treatment, you may have the opportunity to take the active investigational medication (not placebo) for an additional 52 weeks.

Once you have completed the treatment, there will be a 4-week safety follow-up period to monitor your health.

Throughout the study, you will need to visit the study site for tests to check how your body is responding to the study treatment. This will include providing blood and urine samples; eye examinations; questionnaires; chest scans; electrocardiograms (to check your heart) and tests of your lungs.

Length of study treatment

16-68 weeks

Length of study treatment is the length of time the study participants will receive the study treatment.

Total number of study visits

8 or 14

Each clinical trial’s design specifies the number of study visits and the total length of the trial. 8 visits for 16 weeks; 6 additional visits if you continue to 68 weeks.

Safety follow-up

4 weeks

After participants complete the treatment part of the study, they enter a safety follow-up period. During this period, the study team monitors the health of the participants.

Other study requirements

Daily use of moisturizer or emollient on your skin

For some studies, participants must carry out other activities during the study, along with the main study treatment.

About Atopic Dermatitis

Atopic dermatitis (AD, also known as atopic eczema) is a common and chronic skin disease that causes people to experience dry, itchy and discolored patches of skin. Skin normally forms a barrier between the inside of your body and the outside environment. In people with AD, it is thought that this barrier is disrupted, and that the immune system behaves harmfully.

Currently, there is no single systemic treatment (a treatment affecting the whole body) that is viewed as safe and effective for all AD patients. Existing treatments for moderate-to-severe AD can only be used short-term because the treatments are inconvenient or cause side-effects that patients can’t manage. Therefore, there is a need for better treatment options for AD.

Frequently asked questions

Are there any risks?

There are some risks associated with taking part in this study. Taking the study treatment (oral investigational medication or placebo) could make your condition worsen, get better, or stay the same.

Side effects of the study medicine may be mild or serious. A full description of the risks of taking part in this study are given in the informed consent document, which you will be provided with before agreeing to take part in the study.

Your health will be monitored throughout the study. If your health gets worse, a decision will be made between you, the study doctor and the study team about whether you should continue to participate in the study. Your health will be prioritized.

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What is a placebo?

A placebo does not contain any active ingredients, but the study medication and the placebo look alike.

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What is double blind?

Neither you nor the study team will know if the study medication or the placebo is being given.

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Are there any benefits?

You may not receive any benefit from taking part in this study. However, by contributing to research of a treatment for AD, you may help future patients.

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Can I change my mind about taking part?

Yes. Taking part in this study is completely voluntary. You can decide to end your participation at any point during the study and this will not affect your regular medical care.
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