Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Proof of Concept Study Evaluating the Safety and Efficacy of ADX-914 in Subjects with Moderate to Severe Atopic Dermatitis

This research study is looking into a new medication called ADX-914 for adults who have moderate to severe eczema, also known as atopic dermatitis. The main goal is to find out if ADX-914 is safe to use and whether it can effectively improve skin symptoms like itching and redness, compared to a placebo (a dummy pill with no active medicine). We are particularly interested in seeing how much skin symptoms improve over 14 weeks. Researchers will also be monitoring for any side effects and overall how well people tolerate the treatment. This is an important step in developing new treatments for eczema.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Q32 Bio Inc.

Enrolment target

Start

29 Apr 2024

Moderate to Severe Atopic Dermatitis

What is this study about?

This study is about exploring a new medication named ADX-914 for people who live with moderate to severe eczema, also medically known as atopic dermatitis. Eczema can be a very challenging condition, causing itchy, dry, and inflamed skin, which can significantly affect daily life. The goal of this research is to see if ADX-914 can safely and effectively reduce the symptoms of eczema.

In this study, some participants will receive the new medicine ADX-914, while others will receive a placebo, which looks identical but contains no active medication. This is done so researchers can accurately compare the effects of the new medicine against not taking it. Nobody, not even the doctors or the participants, will know who is getting which treatment until the study is over. This helps ensure unbiased results.

The main things we want to learn are about the safety of ADX-914 and how much it improves eczema symptoms. We'll be closely watching for any side effects and using special scores, like the Eczema Area and Severity Index (EASI), to measure changes in skin condition over several weeks. This will help us understand if ADX-914 could be a helpful future treatment option for eczema.

Key takeaways

This study is for adults with moderate to severe eczema.
It's testing a new medicine called ADX-914 for safety and effectiveness.
Some participants will get the new medicine, others a dummy pill (placebo).
Doctors and participants won't know who gets which treatment.
Your eczema symptoms and general health will be regularly checked throughout.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

More specific details about your medical history and current health will be checked by the study staff to make sure the study is a good fit for you and safe for you to participate. This usually involves reviewing your past medical records and undergoing some basic health checks.

It's important that your eczema is considered 'moderate to severe' by the doctors involved in the study. If you're interested, the study team will be able to confirm whether your condition meets the specific criteria needed for this research.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with moderate to severe eczema (atopic dermatitis)?
Are you willing to attend regular study appointments?
Are you comfortable with the possibility of receiving a placebo?
Are you able to understand and follow study instructions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would receive either the new medicine (ADX-914) or a placebo (dummy pill) for a set period. You would need to attend several appointments over the course of the study, where doctors and nurses will check your health, assess your eczema symptoms, and monitor for any side effects. They'll perform various tests like blood tests, physical examinations, and possibly heart checks (ECGs). You'll also be asked about your symptoms and how you're feeling. The study involves regular follow-up visits, so you'll need to be available for these appointments. The exact duration of your participation and the number of visits would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of receiving a new medication that could improve your eczema symptoms. However, as with any new treatment, there are potential risks, including side effects from the medication, which could be mild or, in some rare cases, more serious. There's also a chance you might receive the placebo and not the active drug. Throughout the study, your safety and well-being will be regularly monitored by the medical team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without needing to give a reason, and it will not affect your usual medical care.

Locations (1)

—
Poland

Common questions

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.

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

No, neither you nor the study doctors will know who is getting what until the study is finished. This is called 'double-blind' and helps ensure fair results.

What does 'moderate to severe atopic dermatitis' mean?

It means your eczema symptoms are quite noticeable and may significantly affect your daily life, as assessed by a doctor.

What is an EASI score?

The EASI score is a way doctors measure how severe your eczema is and how much skin is affected, helping to track changes over time.

What happens if I want to stop participating?

You can leave the study at any time, for any reason, and it won't affect your future medical care.