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Apg777

Clinical trials are studying Apg777 in people with moderate-to-severe atopic dermatitis. The trials are checking long-term safety, tolerability, and how well treatment works compared with placebo. They focus on patients with this skin condition in Phase 2 studies.

Table of contents

Trial overview

Two Phase 2 clinical trials are evaluating Apg777 in people with atopic dermatitis, a long-lasting skin condition also called AD in the trial summaries.[1][2]

Both studies are interventional, which means participants receive a study treatment so researchers can compare outcomes between groups.[1][2]

The trials are authorised and are focused on patients with moderate-to-severe disease.[1][2]

Study design and comparison groups

One study is designed to evaluate the long-term safety and effectiveness of Apg777, and it compares Apg777 with placebo.[1]

The other study evaluates the safety and effectiveness of Apg777 and also compares it with placebo.[2]

In the second trial, Part B looks at three different doses of Apg777 compared with placebo after 16 weeks of treatment.[2]

A placebo is a look-alike treatment with no active study drug, used so researchers can see whether Apg777 leads to different results.[1][2]

Who can participate

The main target group in both studies is people with moderate-to-severe atopic dermatitis.[1][2]

The trial data do not list more detailed entry rules, such as age limits or other medical requirements, so the available information only confirms the condition being studied.[1][2]

What the trials measure

The long-term study measures the number of participants with treatment-emergent adverse events over up to 3 years.[1]

Treatment-emergent adverse events are health problems that start or become worse after treatment begins.[1]

The other study measures the percent change from baseline in EASI at Week 16 in Part A.[2]

It also measures the proportion of patients who achieve EASI 75 at Week 16, which means at least a 75% improvement in the EASI score.[2]

EASI stands for Eczema Area and Severity Index, a score used to measure how much skin is affected and how severe the eczema is.[2]

Trial status and size

Both trials are listed as Authorised, meaning they have been approved to move forward in the study process.[1][2]

The long-term safety study plans to include 446 participants, while the other study plans to include 431 participants.[1][2]

The first trial is registered as 2024-519795-11-00, and the second trial is registered as NCT06395948.[1][2]

Terms explained

Baseline means the starting measurement before treatment begins.[2]

Tolerability means how well participants can handle the study treatment during the trial.[1]

Enrollment means the number of people planned for a study.[1][2]

Interventional means the study gives a treatment to participants so outcomes can be compared across groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-519795-11-00 Phase 2 Atopic Dermatitis Authorised 446
NCT06395948 Phase 2 Atopic Dermatitis Authorised 431

FAQ

  • What are the Apg777 clinical trials studying? They are studying Apg777 in atopic dermatitis, a long-term skin condition that causes inflamed, itchy skin. The trials look at safety, tolerability, and how well the treatment works.
  • Who can take part in these trials? The trials are for subjects with moderate-to-severe atopic dermatitis. The data do not give more detailed entry rules, so the main target group is patients with this condition.
  • What phase are the Apg777 trials? Both trials are Phase 2 studies. Phase 2 means the treatment is being tested in patients to learn more about safety and early signs of effectiveness.
  • What do the trials compare Apg777 with? The trials compare Apg777 with placebo. A placebo is a look-alike treatment with no active study drug, used to help show whether Apg777 makes a difference.
  • What results are the trials measuring? One trial measures treatment-emergent adverse events over up to 3 years. The other measures change in EASI at Week 16 and the number of patients who reach EASI 75 at Week 16.

Sperimentazioni cliniche in corso su Apg777

  • Studio a lungo termine per valutare la sicurezza e l’efficacia di APG777 in pazienti con dermatite atopica da moderata a grave precedentemente trattati con APG777

    In arruolamento

    1
    Farmaci in studio:
    Cechia Francia Germania Ungheria Polonia Spagna

  • Studio sulla Sicurezza ed Efficacia di APG777 in Pazienti con Dermatite Atopica Moderata-Grave

    Arruolamento concluso

    1 1
    Farmaci in studio:
    Cechia Francia Germania Ungheria Polonia Spagna

Glossario

  • Atopic dermatitis: A long-lasting skin condition that can cause redness, itching, and inflamed skin. It is also called AD in the trial summaries.
  • Moderate-to-severe: A description of how serious a condition is. In these trials, it means patients have a more significant form of atopic dermatitis.
  • Phase 2: A stage of clinical research in which a treatment is tested in patients to learn more about safety and early effectiveness.
  • Interventional study: A study where participants receive a treatment, such as Apg777 or placebo, so researchers can compare outcomes.
  • Placebo: A look-alike treatment that does not contain the active study drug. It helps researchers compare results fairly.
  • Safety: How well a treatment can be used without causing harmful problems. In these trials, safety is a main focus.
  • Tolerability: How well people can handle a treatment. It includes whether participants can stay on the study drug without major problems.
  • Eczema Area and Severity Index (EASI): A score used to measure how bad eczema is by looking at the area of skin affected and how severe it is.
  • Baseline: The starting point before treatment begins. Trial results are often compared with this first measurement.
  • EASI 75: A result showing at least a 75% improvement in the EASI score. It is used as a sign that the skin condition has improved.
  • Treatment-emergent adverse events: Health problems that start or get worse after treatment begins. The trial tracks these to understand safety.
  • Enrollment: The number of people planned or included in a study.

Riferimenti

  1. https://clinicaltrials.gov/study/2024-519795-11-00
  2. https://studi-clinici.it/studio/studio-sulla-sicurezza-ed-efficacia-di-apg777-in-pazienti-con-dermatite-atopica-moderata-grave/