AuthorisedTherapeutic exploratory (Phase II)Interventional

C6231002 - A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

This research study is for adults who have eczema that is moderate to severe. It's designed to test a new medicine called PF-08049820. The main goal is to find out if this new medicine can significantly improve eczema symptoms, like how red, thick, and itchy the skin is, after 12 weeks. Researchers will also check for any side effects to make sure the medicine is safe. Participants will be put into different groups; some will receive the new medicine in different doses, and others will get a 'dummy' medicine (placebo) that looks the same but has no active ingredients. This helps researchers fairly compare how well the new medicine works against not getting the active treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

14 Apr 2026

Atopic Dermatitis

What is this study about?

Imagine you or someone you know suffers from eczema, a condition that makes your skin red, itchy, and sometimes cracked. For some people, eczema is quite severe and can really affect their daily life. This study is all about trying to find a better way to treat moderate to severe eczema in adults using a new medicine called PF-08049820.

The main aim of the study is to see if this new medicine can help improve eczema symptoms, especially by reducing how much skin is affected and how bad the symptoms are, over a period of 12 weeks. The researchers will be closely watching for how much the eczema improves and will also be checking carefully for any unwanted effects or health changes that might happen because of the medicine. This helps them understand both how effective the medicine is and how safe it is to use.

To make sure the results are fair and reliable, the study is set up so that not everyone will know if they are getting the new medicine or a 'placebo' – which is a treatment that looks exactly like the medicine but doesn't contain any active drug. This is called a 'double-blind' study. There will also be different groups receiving different amounts of the medicine to find the best dose. This careful approach helps doctors learn if the new medicine is a real improvement over current options for managing eczema.

Key takeaways

This study tests a new medicine for adults with moderate to severe eczema.
It aims to find out how well the medicine works and if it's safe.
Some participants will receive the new medicine, others a dummy treatment (placebo).
You must be 18 years or older to participate.
Regular clinic visits and health checks will be part of the study.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are adults, meaning you must be at least 18 years old. There's no upper age limit, so older adults are also welcome to take part if they meet other criteria.

Both men and women can participate in this study. The main requirement for joining is that you have eczema that your doctor would describe as moderate to severe.

Beyond these basic requirements, a doctor on the study team will need to check your medical history and current health to make sure the study is a safe and suitable option for you. They will look for things that might affect how the medicine works or if it could be unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have eczema that a doctor would call 'moderate to severe'?
Are you generally healthy enough to participate in a clinical trial?
Are you able to attend regular clinic appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of several groups by chance. You might receive the new study medicine, or you might receive a look-alike dummy medicine (placebo). Neither you nor your study doctor will know which one you are getting. You'll take the medication as instructed by the study team.

Throughout the study, you'll have regular visits to the clinic. During these visits, doctors and nurses will check your general health, measure your eczema symptoms (like redness, thickness, and itchiness), and sometimes take blood samples or perform other tests like checking your heart activity with an ECG. These checks help the researchers understand how the medicine is affecting your eczema and your overall health. The specific number of visits and the total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might benefit from closer medical attention and potentially from the new medicine if it proves effective for your eczema. However, there's no guarantee the new medicine will help you, and you might experience side effects, some of which could be serious. The study team will explain all known potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Czechia
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Unverified
Germany
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Unverified
Bulgaria
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Unverified
France

Common questions

What is 'moderate to severe atopic dermatitis'?

It's another name for eczema that is causing significant problems with your skin, like widespread redness, itching, and dryness, impacting your daily life.

What does 'double-blind' mean in a study?

It means neither you nor your study doctor will know if you're getting the active medicine or the dummy medicine. This helps keep the study fair and unbiased.

What is a 'placebo'?

A placebo is a substance that looks exactly like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine to see if it truly works better.

Will I have to pay to be in this study?

Typically, clinical trials cover the costs of study-related medicine and appointments. The study team will confirm any potential costs or reimbursements for travel.

How long will the study last for me?

This study is focused on results after 12 weeks, but your full participation, including follow-up, could be longer. The study team will give you a clear timeline.