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RekrutierungPHASE2INTERVENTIONELL

A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

This research study is looking at a new medicine called KT-621 for people aged 12 to 75 who have moderate to severe atopic dermatitis (a common type of eczema). The main goals are to find out how well KT-621 works to clear up eczema, if it's safe to use, and how it affects the body. For the first 16 weeks, some participants will receive KT-621 and others will get a placebo (a dummy medicine), and neither you nor your doctor will know which you are receiving. After this, everyone will have the chance to receive KT-621 for a longer period. This will help us understand if KT-621 could be a helpful new treatment option for eczema.

Auf einen Blick

Status
Rekrutierung
Phase
PHASE2
Sponsor
Kymera Therapeutics, Inc.
Einschreibeziel
200
Starten
24. Nov 2025
Geschätzte Fertigstellung
01 Jun 2028

Worum geht es in dieser Studie?

Atopic dermatitis, often called eczema, is a common skin condition that causes red, itchy, and inflamed patches on the skin. It can be uncomfortable and sometimes painful. When current treatments aren't enough, doctors and researchers look for new ways to help manage these symptoms.

This study is investigating a new medicine called KT-621. We want to see if this medicine can effectively reduce the itching, redness, and overall severity of eczema for people who have moderate to severe forms of the condition. We'll also be carefully checking for any side effects and learning how the medicine works inside the body.

This research is important because it could lead to a new treatment option for people living with eczema. Finding more effective and safer treatments can significantly improve the quality of life for many individuals affected by this condition.

Wichtige Erkenntnisse

  • This study tests a new medicine (KT-621) for moderate to severe eczema.
  • It's for adults and teenagers (12-75 years old) whose current treatments aren't enough.
  • The study aims to check if KT-621 is safe and effective by comparing it to a dummy pill.
  • Participation involves regular clinic visits, taking the medicine by mouth, and using an e-diary.
  • You'll be closely monitored by doctors and can leave the study at any time.
  • It could lead to a new treatment option for people with eczema.

Wer könnte berechtigt sein?

To join this study, you need to be between 12 and 75 years old. You should have had eczema for at least three years if you're an adult, or at least one year if you're under 18. Your eczema needs to be moderate to severe, covering at least 10% of your body, and causing significant itchiness.

It's important that your current eczema treatment, such as creams, hasn't been working well enough for at least six months, or you haven't been able to use them for other reasons. You'll also need to be using moisturiser regularly before and during the study.

You wouldn't be able to join if your eczema is getting rapidly better or worse, or if you have other skin conditions that might make it hard to tell if the new medicine is working. People with other serious health problems affecting major body systems could also be excluded.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Are you between 12 and 75 years old?
  2. Have you had moderate to severe eczema for at least a year (if under 18) or three years (if 18 or older)?
  3. Do your current eczema treatments not work well enough for you?
  4. Do you use moisturiser regularly on your skin?
  5. Is your eczema causing significant itchiness?
  6. Do you not have other serious skin conditions (like psoriasis) that could be confused with your eczema?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. If you qualify, you'd be in the study for a total of about 68 weeks. The first 16 weeks involve regular visits to the clinic, where you might receive either the study medicine (KT-621) or a dummy medicine (placebo). Neither you nor the study team will know which you are receiving during this period. After these initial 16 weeks, all eligible participants will have the opportunity to take KT-621 for another 52 weeks.

During your visits, you'll have check-ups, blood tests, and we'll ask you questions about your eczema and how you're feeling. You'll also be asked to keep a record of your symptoms and how itchy you are using an electronic diary. All participants will take the study medicine by mouth, and you'll need to follow specific instructions on how and when to take it. There will be planned follow-up appointments and assessments throughout the study timeline.

Potenzielle Risiken und Vorteile

Taking part in a research study means you might benefit from receiving a new treatment for your eczema that isn't widely available yet, and your health will be closely monitored by medical professionals. However, there's no guarantee that the new medicine will help your eczema, and it might have side effects that we don't fully know about yet. You might also receive a placebo, which means you won't be getting the active study drug during the initial phase. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (67)

  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Birmingham, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    North Little Rock, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Nur Stadt
    Freemont, United States· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Los Angeles, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Los Angeles, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Santa Monica, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Delray Beach, United States· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Miami, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Miramar, United States· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Normal, United States· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Indianapolis, Vereinigte Staaten· Rekrutierung
  • Kymera Investigative Site
    Verifizierte Postleitzahl
    Ann Arbor, Vereinigte Staaten· Rekrutierung

Häufige Fragen

What is KT-621?

KT-621 is a new, investigational medicine that is being tested to see if it can help improve the symptoms of moderate to severe eczema.

What is atopic dermatitis (eczema)?

Atopic dermatitis is a long-lasting skin condition that causes patches of dry, itchy, and inflamed skin. It's often called eczema.

Was bedeutet 'doppelblind, placebokontrolliert'?

It means for the first part of the study, some people will get KT-621 and some will get a dummy pill (placebo). Neither you nor your doctor will know which you are receiving, which helps us fairly assess the medicine's effects.

Wie lange wird die Studie dauern, wenn ich teilnehme?

If you meet the requirements and join, you'll be involved in the study for around 68 weeks in total.

Can I stop participating in the study at any time?

Ja, Sie können sich jederzeit entscheiden, die Studie zu verlassen, ohne dass dies Ihre medizinische Versorgung beeinträchtigt.

Wie Sie mehr erfahren können

Kymera Medical Director

Sprechen Sie immer mit Ihrem Hausarzt oder Spezialisten, bevor Sie sich entscheiden, an einer Studie teilzunehmen.

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