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Apg777

Clinical trials are studying Apg777 in people with moderate-to-severe atopic dermatitis, also called eczema. These studies aim to check long-term safety, tolerability, and how well Apg777 works compared with placebo. Both trials are Phase 2 and are enrolling adults with this skin condition.

Table of Contents

Trial overview

Clinical trials of Apg777 are being done in people with atopic dermatitis, which is also called eczema.[1][2] Both studies are Phase 2 and are currently authorised.[1][2]

The two trials are looking at whether Apg777 can help people with moderate-to-severe disease and whether it can be used safely over time.[1][2]

Who is being studied

Both studies focus on patients with moderate-to-severe atopic dermatitis, meaning eczema that is more serious and can affect daily life more strongly.[1][2]

The trial data do not list full eligibility rules, but the target population is clearly adults or patients with this skin condition who meet the study criteria.[1][2]

Study designs and phases

Both studies are interventional, which means the researchers give a study treatment and then measure what happens.[1][2]

One study is designed to evaluate the long-term safety and effectiveness of Apg777, with follow-up for up to 3 years.[1]

The other study compares Apg777 with placebo, which is a look-alike treatment with no active study drug, to see whether Apg777 works better than no active treatment.[2]

Outcomes being measured

The long-term study measures the number of participants with treatment-emergent adverse events, meaning health problems that start after treatment begins, over a period of up to 3 years.[1]

The other study measures change in Eczema Area and Severity Index (EASI) from baseline to Week 16 in Part A.[2] Baseline means the starting point before treatment begins.[2]

In Part B, the same study measures the proportion of patients who achieve EASI 75 at Week 16, which means a 75% or greater improvement in the EASI score from the start of the trial.[2]

Key trial details

Trial 2024-519795-11-00 includes 446 participants and focuses on long-term safety and effectiveness in atopic dermatitis.[1]

Trial NCT06395948 includes 431 participants and has two parts: one looks at overall change in EASI after 16 weeks, and the other compares different doses of Apg777 with placebo after 16 weeks.[2]

Both studies are important because they help show whether Apg777 may be useful for patients with moderate-to-severe eczema and how its effects compare with placebo.[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 is being studied in Apg777 clinical trials? The trials are studying whether Apg777 is safe and whether it helps improve atopic dermatitis. One study also looks at long-term safety over up to 3 years.
  • Who can take part in these trials? People with moderate-to-severe atopic dermatitis may be eligible. The trial data do not give all entry rules, but the target group is patients with this skin condition.
  • What phase are the Apg777 trials in? Both trials are Phase 2 studies. This phase usually looks at early evidence of benefit and continues to check safety.
  • What condition is Apg777 being tested for? Apg777 is being tested for atopic dermatitis, which is also called eczema. This is a long-term skin condition that can cause itchy, inflamed skin.
  • What outcomes are the trials measuring? One trial measures treatment-emergent adverse events, which means health problems that start after treatment begins. The other trial measures changes in EASI and the number of people who reach EASI 75 at Week 16.

Ongoing Clinical Trials on Apg777

  • Long-term safety and effectiveness study of APG777 injection in patients with moderate-to-severe atopic dermatitis who previously received APG777 treatment

    Recruiting

    2 1
    Investigated drugs:
    Czechia France Germany Hungary Poland Spain

  • Study on the Safety and Effectiveness of APG777 for Patients with Moderate-to-Severe Atopic Dermatitis

    Not recruiting

    2 1 1
    Investigated drugs:
    Czechia France Germany Hungary Poland Spain

Glossary

  • Atopic dermatitis: A long-term skin condition, also called eczema, that can cause dry, itchy, and inflamed skin.
  • Moderate-to-severe: A level of illness that is more than mild and can cause stronger symptoms or more impact on daily life.
  • Phase 2: A stage of clinical research that looks at early signs of how well a treatment works and continues to study safety.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Interventional study: A trial where researchers give a treatment and then watch what happens.
  • Safety: How well a treatment is tolerated and whether it causes unwanted health problems.
  • Tolerability: How easy a treatment is to take or receive, based on side effects and comfort.
  • Eczema Area and Severity Index (EASI): A score used to measure how serious eczema is and how much skin is affected.
  • EASI 75: A result meaning a person’s EASI score improved by 75% or more from the start of the study.
  • Treatment-emergent adverse events: Health problems that begin or get worse after treatment starts, whether or not they are caused by the study treatment.
  • Baseline: The first measurement taken before treatment begins, used as a starting point for comparison.
  • Week 16: A study time point 16 weeks after treatment starts.

References