An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis
This research study is for adults with eczema (atopic dermatitis) that is moderate to severe and hasn't improved much with usual skin creams. The main aim is to see how safe a combination of two new medicines, APG777 and APG990, are when compared to a widely used eczema treatment called dupilumab. Researchers will also check how well the new medicines are tolerated by the body. Taking part would mean you would be in the study for about 82 weeks (around a year and a half). This includes initial checks, a period where you take the study medicine, and then a follow-up time to see how you're doing. It's a way to find out if these new medicines could be a helpful option in the future for people with eczema.
At a glance
What is this study about?
This research study is about finding new ways to treat moderate to severe eczema, also known as atopic dermatitis. Eczema can be a really challenging condition, causing itchy, dry, and uncomfortable skin. While there are treatments available, researchers are always looking for even better options. This particular study is focusing on two new medicines, APG777 and APG990, given together.
The main goal is to understand how safe these two new medicines are when used in combination, and how well people's bodies handle them. To do this, the study will compare the new combination treatment with a medicine already approved and used for eczema called dupilumab. This comparison will help doctors see if the new combination could be a useful treatment in the future. It's important to remember that this is an early-stage study, so it's focused on safety and how the body processes the medication.
The study will last for quite a while, around 82 weeks (about 19 months) in total for each person who takes part. This includes an initial check-up period, a time when you would be taking the study medicine, and then a follow-up period where doctors will continue to monitor your health and how you're feeling. During the study, you'll either receive the new combination treatment or dupilumab. The choice of which treatment you get is made randomly, like flipping a coin, to make the comparison as fair as possible.
Key takeaways
- The study is testing new medicines for moderate to severe eczema.
- It compares two new drugs (APG777 + APG990) with an existing treatment (dupilumab).
- The main focus is on how safe the new combination is.
- Participation lasts about 82 weeks, including treatment and follow-up.
- You might receive the new combination or the existing treatment, decided by chance.
Who may be eligible?
To be considered for this study, you need to be an adult (18 years or older) and have been diagnosed with eczema (atopic dermatitis) for at least a year. Your eczema should be considered moderate to severe at the time you join the study, and you should have tried topical (on-the-skin) treatments in the past that haven't worked well enough for you.
There are also some reasons why you might not be able to join. For example, if you've been in a study for either APG777 or APG990 before, or if you've recently used certain strong medicines for your eczema, you wouldn't be able to take part. It's also important that you don't have severe allergic reactions to any of the study medications or other health conditions that might make it difficult to properly assess the effects of the treatment.
For women who could become pregnant, you would need to have negative pregnancy tests before and at the start of the study. The doctors will discuss all the specific rules and checks with you if you're interested, to make sure the study is right for you and safe.
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 had eczema (atopic dermatitis) for at least a year?
- Is your eczema currently moderate to severe?
- Have topical skin treatments not worked well enough for your eczema?
- Are you able to commit to about a year and a half for the study duration?
What does participation involve?
If you decide to take part in this study, the total time involved will be around 82 weeks, which is about a year and a half. This time is split into a few parts: first, a screening period of up to 6 weeks where doctors will check if you're suitable. Then, there's a treatment period lasting 24 weeks where you'll receive either the new medicines or dupilumab. Finally, there's a follow-up period of about a year (48 weeks) where the team will monitor your health.
During the study, you'll have regular visits to the clinic for assessments. These checks will include looking at your eczema, asking about your health and how you're feeling, and taking blood or urine samples. You'll receive one of the study treatments, but you won't get to choose which one; it will be decided randomly. The study team will explain everything to you in detail, including how to take your medication and what to expect at each appointment.
Potential risks and benefits
Locations (20)
- Investigational SiteVerified postcodeDarlinghurst, Australia
- Investigational SiteVerified postcodeKogarah, Australia
- Investigational SiteVerified postcodeWestmead, Australia
- Investigational SiteVerified postcodeWoolloongabba, Australia
- Investigational SiteVerified postcodeCarlton, Australia
- Investigational SiteVerified postcodeEast Melbourne, Australia
- Investigational SiteVerified postcodeMitcham, Australia
- Investigational SiteVerified postcodeParkville, Australia
- Investigational SiteVerified postcodeFremantle, Australia
- Investigational SiteVerified postcodeLondon, Canada
- Investigational SiteVerified postcodePeterborough, Canada
- Investigational SiteVerified postcodeRichmond Hill, Canada
Common questions
What is eczema (atopic dermatitis)?
Eczema is a common, long-lasting skin condition that causes itchy, dry, and inflamed patches of skin.
What are APG777, APG990, and dupilumab?
APG777 and APG990 are new medicines being tested, while dupilumab is an existing medicine used for eczema.
How long will I be in the study?
If you join, the study will last for about 82 weeks (around a year and a half) in total.
Will I know which treatment I'm getting?
No, you won't know initially. The treatment you get (new combination or dupilumab) will be decided by chance, like drawing lots.
Can I leave the study at any time?
Yes, you can choose to leave the study at any point, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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