Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

B7451015 - A PHASE 3 MULTICENTER, LONG-TERM EXTENSION STUDY INVESTIGATING THE EFFICACY AND SAFETY OF ABROCITINIB, WITH OR WITHOUT TOPICAL MEDICATIONS ADMINISTERED TO SUBJECTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS

This research study is for people aged 12 and up who have moderate to severe eczema. It's investigating a medicine called Abrocitinib, also known as Cibinqo. The main goal is to understand how well this medicine works over a long period and if it's safe to use. Some participants might use the medicine alongside their usual skin creams, while others might receive a dummy pill (placebo) instead of Abrocitinib to help compare the effects. Researchers will be carefully monitoring any side effects, how much the eczema improves, and how it affects daily life and overall well-being. This type of study, called a Phase 3, helps confirm if a new treatment is effective and can potentially be made available to more people in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Pfizer Inc.

Enrolment target

735

Start

17 May 2024

Moderate to severe atopic dermatitis

What is this study about?

This important long-term study is designed for individuals aged 12 and older who are living with moderate to severe eczema, also known as atopic dermatitis. Eczema can make your skin very itchy, red, and dry, and for some, it can be quite challenging to manage in daily life. This study is focusing on a specific medication called Abrocitinib, which you might know by its brand name, Cibinqo.

The main purpose of this research is to build on previous findings and see how safely and effectively Abrocitinib works over a longer period. This will help doctors and researchers understand its real-world benefits. Some people taking part might also continue using their usual skin creams while on the study medication, while others will receive a placebo – which looks like the medication but contains no active drug. Comparing the effects of Abrocitinib to a placebo helps researchers understand the true benefits of the medicine.

Throughout the study, the research team will be carefully watching for several things. They'll be tracking any side effects that might happen, how much the eczema improves, and how your overall quality of life might change. This includes looking at things like how much the itching is reduced, how well you sleep, and how your mood might be affected. All this information helps to get a full picture of the medication's impact.

Key takeaways

This study is for people aged 18 and older (or from 12 in the wider study) with moderate to severe eczema.
It tests a drug called Abrocitinib (Cibinqo) to see if it's safe and effective long-term.
Some participants will get the actual medicine, others a placebo (dummy pill).
You'll have regular clinic visits, health checks, and blood tests.
The study aims to improve eczema symptoms and overall quality of life.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To be part of this study, you generally need to be at least 18 years old. The information provided specifically mentioned "18 Years to any" for age, which means adults aged 18 and over are eligible. However, the trial title mentions a broader age range: "aged 12 years and older." This might mean that while the current listed eligibility focuses on adults, there may have been separate parts of the study or related studies that included younger individuals.

Whether you are male or female, you can take part in this study. The main medical requirement is that you have moderate to severe atopic dermatitis, which is the medical term for eczema.

There will be other, more detailed reasons why someone might or might not be able to join, which a doctor and the study team would discuss with you. These reasons are put in place to ensure the safety of participants and the accuracy of the study results. It's always best to speak with the research team directly to confirm if you meet all the specific criteria.

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?
Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
Are you willing and able to attend regular clinic visits?
Are you able to take a tablet daily as directed?
Are you open to the possibility of receiving a placebo instead of the active drug?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either the study drug, Abrocitinib (Cibinqo), or a placebo (a dummy pill that looks the same but contains no active medicine). You'll take these as tablets, likely once a day. Some participants might also continue using their regular skin medications alongside the study drug.

You'll have regular visits to the clinic, which will be planned out for you. During these visits, doctors and nurses will check your general health, measure your eczema symptoms, and ask you about how you're feeling and how your skin condition is affecting your daily life. They will also do some tests like blood tests, check your heart with an ECG (electrocardiogram), and take your blood pressure.

These check-ups are essential for the researchers to understand how the medication is working and to ensure your safety. The total time you'd be involved in the study would be over a longer period, as it's designed as a "long-term extension study," meaning it follows on from initial studies. You'll receive a detailed schedule if you decide to participate.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit could be that your eczema symptoms might improve, which could lead to better sleep, less itching, and an improved quality of life. You'll also receive careful medical monitoring throughout the study. However, there's no guarantee that the treatment will work for you, and there's a chance you might experience side effects, as with any medication. These can range from mild to serious. Because some people receive a placebo, your eczema might not improve. You're free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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
Hungary
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Unverified
Spain

Common questions

What is Abrocitinib (Cibinqo)?

Abrocitinib, also known as Cibinqo, is a medicine being studied for moderate to severe eczema (atopic dermatitis).

What is 'moderate to severe atopic dermatitis'?

This means your eczema is more than just mild; it significantly affects your skin, causing itching, dryness, and sometimes pain or infection, and can impact your daily life.

Will I definitely receive the study drug?

Not necessarily. In studies like this, some participants receive the active study drug, while others receive a placebo (a dummy pill with no medicine) to help compare effectiveness.

What is a 'long-term extension study'?

This means the study follows on from earlier research, allowing doctors to gather more information about the medicine's effects and safety over a longer period of time.

What age do I need to be?

Based on the eligibility details provided, you need to be at least 18 years old to participate, though the study title also mentions people aged 12 and older.