Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis

This research study is looking at a new medicine called ANB032 for people who have moderate to severe atopic dermatitis, also known as eczema. Eczema can make your skin very itchy, red, and dry. The study will compare ANB032 to a 'dummy' treatment (placebo) and some existing eczema creams (alclometasone and hydrocortisone) to see how well it works. We want to find out if ANB032 can significantly improve eczema symptoms and if it's safe for people to use. This kind of study helps doctors understand if new medicines are helpful before they can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Anaptysbio Inc.

Enrolment target

Start

13 Mar 2024

Atopic Dermatitis

What is this study about?

This study is about a skin condition called atopic dermatitis, more commonly known as eczema. If you have eczema, you know it can cause red, itchy, and inflamed patches of skin. For some people, eczema can be moderate to severe, meaning it significantly affects their daily life.

The researchers are testing a new medicine called ANB032. They want to see if it can help improve eczema symptoms and if it's safe for people to use. To do this, they will compare ANB032 to two things: a 'placebo' (which looks like the study medicine but has no active ingredients) and some common eczema creams like alclometasone and hydrocortisone. This comparison helps them understand if ANB032 is truly making a difference.

The main goal is to find out if ANB032 can reduce eczema symptoms by at least 75% after 14 weeks of treatment. This specific measure helps doctors tell if the new medicine is having a real, noticeable effect on your skin. If the study shows promising results, it could mean new treatment options for people living with eczema.

Key takeaways

This study is testing a new medicine (ANB032) for eczema.
It's for adults with moderate to severe eczema.
The new medicine will be compared to a dummy treatment and existing creams.
The goal is to see if ANB032 can significantly improve eczema symptoms.
Participation involves regular clinic visits and health checks.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Because this study is specifically looking at eczema, you must have been diagnosed with moderate to severe atopic dermatitis by a doctor. This means your eczema is quite bothersome and not just a mild irritation.

There will be other health checks and requirements to make sure the study is safe and suitable for everyone taking part. Your study doctor or nurse will check all of these with you carefully.

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 a diagnosis of moderate to severe eczema (atopic dermatitis)?
Are you comfortable committing to regular clinic visits?
Are you willing to potentially receive a placebo or an existing treatment?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of several groups. Some groups will receive the new medicine, ANB032, while others might get the dummy treatment (placebo), or one of the existing eczema creams (alclometasone or hydrocortisone). You, and often the study team, won't know which treatment you're receiving – this is called 'double-blind'.

You'll have regular visits to the study clinic, where doctors and nurses will check your health and how your eczema is doing. They'll assess your skin, ask about your symptoms, and you might have blood tests or other checks. You'll be given the study medicine as an injection, and will need to apply any creams as instructed.

The study will last for a certain period, and after the main treatment phase, there will be follow-up appointments to monitor your health. The total duration of your participation, including all visits and follow-ups, will be clearly explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your eczema. However, there's a chance the new treatment might not work for you, or you could experience side effects. The study team will explain all known risks of the treatments. Remember, you can always change your mind and leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What is 'moderate to severe atopic dermatitis'?

This means your eczema is quite bothersome, causing significant itching, redness, and discomfort that affects your daily life.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the study medicine but doesn't contain any active ingredients. It helps researchers see if the real medicine is actually working.

Will I know if I'm getting the new medicine or the placebo?

No, usually neither you nor your study doctor will know which treatment you're receiving. This is to make sure the study results are fair and unbiased.

How long will I be in the study?

The study's total length, including all treatment and follow-up visits, will be explained in detail by the study team before you decide to join.

Can I leave the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your regular medical care.