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RekryteringFAS2INTERVENTIONELL

A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis

This study is checking a new medicine called APG777 for people with moderate-to-severe eczema (atopic dermatitis). It's a follow-on study for people who have already been taking APG777 in an earlier trial and whose doctors believe they are benefiting from it. The main purpose is to see how safe and effective APG777 is when used for a longer period. Participants will continue to use APG777 and will have regular check-ups. The study will look closely at any side effects and how well the medicine continues to control their eczema. There will also be a follow-up period after they finish taking the medicine.

Överblick

Status
Rekrytering
Fas
FAS2
Sponsor
Apogee Therapeutics, Inc.
Inskrivningsmål
350
Starta
14 maj 2025
Beräknad slutförande
01 dec 2029
Atopic Dermatitis

Vad handlar denna studie om?

This study is about a new medicine called APG777 for a skin condition known as atopic dermatitis, which is a common type of eczema. Specifically, it's for people who experience moderate to severe forms of this condition. Doctors are trying to find new and better ways to manage eczema that can be very uncomfortable and affect daily life.

This particular study is a "long-term extension," which means it follows on from an earlier study where people were taking APG777 for a shorter time. If you were in one of these earlier studies, and your doctor thinks APG777 has helped you and you would benefit from continuing the treatment, then you might be able to join this study. The main goal is to understand how safe APG777 is and how well it continues to work over a much longer period.

The researchers will closely monitor participants to see if there are any side effects with long-term use and to make sure the medicine keeps helping to control their eczema. This kind of information is really important for doctors to understand if APG777 could be a valuable long-term treatment option for people with moderate to severe atopic dermatitis in the future.

Viktiga punkter

  • This study evaluates APG777 for moderate-to-severe eczema.
  • It's for adults who were in an earlier APG777 study.
  • The main goal is to check long-term safety and how well it works.
  • Participation involves continued medication and regular check-ups.
  • You will be monitored for side effects and eczema improvement.
  • Du kan lämna studien när som helst.

Vem kan vara berättigad?

This study is designed for adults aged 18 and over who have moderate-to-severe eczema (atopic dermatitis). You must have already taken part in an earlier study for APG777 and have completed the treatment part of that study. Your study doctor from the previous trial must also believe that you followed all the study rules and that continuing with APG777 would be good for your eczema.

You will also need to continue using the same non-prescription moisturisers you used during the last part of the previous study throughout this new study.

You would not be able to join if you had a significant side effect or problem in the previous study that your doctor felt made it unsafe for you to continue with APG777. Also, if you stopped the previous study early, or if you are using any medicines that were not allowed in the previous study, you would not be eligible. Finally, if you have other skin conditions or health problems that could make it difficult to properly assess your eczema or the effects of the study medicine, you would likely not be able to take part.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  1. Är du 18 år eller äldre?
  2. Have you previously completed an APG777 study for eczema?
  3. Does your doctor feel APG777 has helped your eczema?
  4. Are you able to use the same non-prescription moisturisers throughout the study?
  5. Did you *not* leave your previous APG777 study early due to a major side effect?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

If you join this study, it actually starts at the same time as your last visit for the previous APG777 study. You will continue to take APG777 as prescribed. You'll have regular clinic visits where the study team will check your health, assess your eczema, and ask about any side effects you might be having. They will monitor how well the treatment is working and make sure you are safe. After you finish taking the study medicine, there will be a follow-up period with at least one more visit to check on your health and ensure there are no lasting effects. The total length of your participation is not specified but is considered a long-term commitment.

Potentiella risker och fördelar

Participating in this study might offer you continued benefit if APG777 has been helping your eczema, and it could contribute to important medical knowledge. However, as with any medicine, there's always a chance of side effects, some of which might appear or become more noticeable with longer use. The study team will monitor you closely for any health changes. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Platser (79)

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    Fountain Valley, United States· Rekrytering
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    Los Angeles, USA· Rekrytering
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    Coral Gables, United States· Rekrytering
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    Margate, United States· Rekrytering
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    Rockville, United States· Rekrytering
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    Detroit, USA· Rekrytering
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    Troy, United States· Rekrytering
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    New York, USA· Rekrytering

Vanliga frågor

Vad är atopisk dermatit?

Atopic dermatitis is a common, long-lasting skin condition also known as eczema, which causes itchy, red, dry, and inflamed skin.

Why is this study only for people who were in a previous APG777 study?

This is a follow-on study to see how safe and effective APG777 is when used for a longer time, after people have already tried it in an earlier study.

What is meant by 'long-term extension'?

It means the study continues treatment you started in an earlier trial, extending the period you take the medicine to gather more information over a longer time.

Will I know if I'm taking APG777 or a dummy drug?

This study is 'double-blind,' meaning neither you nor your study doctor will know if you are receiving APG777 or a placebo (dummy drug) to ensure fair results.

Vad händer om jag upplever biverkningar?

The study team will monitor you closely for any side effects and will provide care and guidance. You can discuss any concerns with them at any time.

Hur du får reda på mer

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