Active not recruitingPHASE2INTERVENTIONAL

A Study Evaluating APG777 in Atopic Dermatitis

This research study is investigating a new medication called APG777 for people with moderate to severe eczema, also known as atopic dermatitis. The main goal is to find out if APG777 is safe and effective in reducing eczema symptoms. The study is split into two parts: one to explore if the medicine works, and another to figure out the best dose. Participants will receive either APG777 or a placebo (a dummy medicine with no active ingredients). Involvement in the study could last up to 106 weeks, which includes initial checks, treatment periods, and follow-up appointments. Doctors hope this research will lead to better treatment options for people living with eczema.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Apogee Therapeutics, Inc.

Enrolment target

470

Start

29 Apr 2024

Estimated completion

01 Jun 2028

Atopic Dermatitis

What is this study about?

This research is looking into a new medication called APG777, designed to treat moderate to severe eczema (atopic dermatitis). Eczema is a common skin condition that causes dry, itchy, and inflamed skin. For many people, existing treatments don't always provide enough relief, so scientists are always looking for new and more effective options.

The study aims to understand two main things about APG777: first, how safe it is for people to use, and second, how well it works to improve eczema symptoms compared to a 'placebo' (a dummy medicine that looks the same but has no active drug). By comparing APG777 to a placebo, researchers can clearly see if any benefits are due to the new medicine.

The study has two stages. The first stage focuses on seeing if APG777 has a noticeable effect on eczema. The second stage then helps researchers find the most effective and safest dose of APG777 for patients. This careful approach helps ensure that any new medicine is thoroughly tested before it can become widely available.

Key takeaways

The study is testing a new medicine, APG777, for moderate to severe eczema.
It aims to find out if APG777 is safe and effective compared to a dummy medicine.
Participation could last up to two years, involving regular clinic visits.
You might receive APG777 or a placebo; neither you nor the doctors will know which.
You must be an adult with chronic eczema that hasn't responded well to standard creams.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been diagnosed with eczema for at least one year. Your eczema should be considered moderate to severe at the time you join the study. It's also important that your current skin treatments (like creams) haven't been working well enough for you, or your doctor feels they aren't suitable for you anymore. You should also be regularly using a plain moisturiser and be willing to keep using it throughout the study.

There are also some reasons why you might not be able to join. For example, if you've been in a previous study testing this specific medicine (APG777), you won't be able to take part this time. You also can't have recently used certain other powerful eczema medications, including particular types of injections or strong skin creams, or treatments like light therapy within a few weeks of starting the study.

Crucially, you would need to have been using a stable, non-medicated moisturiser for at least two weeks before the study starts and be able to fill out itch questionnaires electronically for most days in the week leading up to the study's start.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with eczema (atopic dermatitis) for at least a year?
Is your eczema currently moderate to severe?
Are your current eczema creams and treatments not managing your symptoms well enough?
Have you been regularly using a plain moisturiser for the past two weeks?
Have you *not* participated in a previous study with this specific medicine (APG777)?

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 in this study, your involvement could last for up to 106 weeks, which is about two years. This time includes a few different stages:

* **Screening:** This is when doctors will check if you meet all the requirements to join the study. This will likely involve examinations and questions about your health and eczema. * **Treatment Periods:** If you qualify, you'll be given either the new medicine (APG777) or a placebo (a dummy medicine) through injections, and you won't know which one you are receiving. You'll have regular visits to the clinic so the medical team can monitor how you're responding and check for any side effects. * **Follow-up:** After your treatment period finishes, you'll have some final check-ups to make sure you're doing well and to collect any last pieces of information.

Throughout the study, you'll also be expected to use a plain moisturiser regularly and fill out electronic questionnaires about your itching. You will have regular appointments at the clinic for check-ups and to receive your study medication.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment (APG777) that isn't yet widely available and might improve your eczema. You'll also receive careful medical monitoring throughout the study. However, like all medicines, APG777 may have side effects, and since it's an investigational drug, not all side effects are known yet. Some people might receive a placebo and therefore not experience any direct benefits from the study drug. Research studies can also be time-consuming with multiple clinic visits. It’s important to remember that participating is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (94)

Investigational Site
Fountain Valley, United States
Investigational Site
Los Angeles, United States
Investigational Site
San Diego, United States
Investigational Site
New Haven, United States
Investigational Site
Coral Gables, United States
Investigational Site
Jacksonville, United States
Investigational Site
Margate, United States
Investigational Site
Douglasville, United States
Investigational Site
Chicago, United States
Investigational Site
Skokie, United States
Investigational Site
West Lafayette, United States
Investigational Site
Bowling Green, United States

+82 more sites — see the official record for the full list.

Common questions

What is APG777?

APG777 is a new medicine being tested to see if it can help improve moderate to severe eczema (atopic dermatitis).

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the study drug but contains no active ingredients. It helps researchers see if any changes are truly due to the new medicine.

How long will I be in the study?

Your involvement in the study could last for up to 106 weeks, which is about two years, including check-ups and treatment periods.

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

No, this is a 'blinded' study, meaning neither you nor the study doctors will know if you are receiving APG777 or the placebo.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, and it will not affect your regular medical care.