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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with atopic dermatitis, a chronic inflammatory skin condition that causes itchy, red, and inflamed skin. The research evaluates a medication called APG777, which is given as a subcutaneous injection (an injection under the skin). The purpose is to assess the long-term safety and effectiveness of APG777 in people with moderate-to-severe atopic dermatitis who have previously received this treatment.

The study will involve participants who have already completed an earlier trial of APG777. During this extended treatment period, participants will continue receiving APG777 injections for up to three years. Some participants may receive a placebo during the study. Throughout the study, participants will be allowed to use non-medicated moisturizers to help manage their skin condition.

The research will monitor how well the medication controls atopic dermatitis symptoms over time, including improvements in skin appearance, reduction in affected areas, and relief from itching. The study will also track any side effects that may occur during the extended treatment period. Regular assessments will measure the amount of APG777 in participants' blood to understand how the medication works in the body over a longer period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    You must have completed a previous APG777 treatment study and followed all study requirements correctly

    Your doctor needs to confirm that continuing treatment with APG777 would be beneficial for your atopic dermatitis

    You need to continue using the same non-prescription moisturizer that you used in your previous study

  2. Step 2

    Treatment period

    You will receive APG777 through subcutaneous injection (injection under the skin)

    The treatment period will last approximately 2-3 years

    Regular monitoring of your skin condition will occur using specific measurement tools:

    - Assessment of the extent and severity of your atopic dermatitis

    - Evaluation of skin clearance

    - Tracking of daily itching intensity using a rating scale

  3. Step 3

    Ongoing assessments

    Your doctor will monitor any side effects throughout the study period

    Blood samples will be taken to measure the levels of APG777 in your body

    Your use of any additional treatments for atopic dermatitis will be recorded

    The effectiveness of the treatment will be regularly evaluated through skin examinations

  4. Step 4

    Study duration

    The study is expected to run from October 2025 to December 2029

    Your participation may last up to 3 years

    Regular clinic visits will be required throughout the study period for monitoring and assessments

Who can join the trial?

7 criteria

  • Must have previously participated in and completed treatment with APG777 in an earlier study
  • Must have followed all study rules and instructions properly during the previous study, as determined by the study doctor
  • The study doctor must believe that continuing long-term treatment with APG777 would be beneficial for the patient
  • Must be willing to continue using the same non-prescription moisturizer that was used in the previous study throughout this extended study period
  • Must be either male or female
  • Must be an adult (age 18-64) or elderly (age 65+)
  • Must have moderate-to-severe atopic dermatitis (a chronic inflammatory skin condition causing itchy, dry, and irritated skin)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • History of severe allergic reactions to medications
  • Pregnancy or breastfeeding
  • Active skin infections
  • Current participation in other clinical trials
  • Use of other treatments for atopic dermatitis in the past 4 weeks
  • Serious medical conditions that could interfere with the study, such as liver disease, kidney disease, or cancer
  • History of immunosuppression (weakened immune system)
  • Significant skin conditions other than atopic dermatitis
  • Mental health conditions that could affect ability to follow study procedures
  • Substance abuse within the past year
  • History of poor compliance with medical treatments
  • Blood disorders or abnormal blood test results
  • Serious heart conditions or uncontrolled high blood pressure
  • Unable to attend regular study visits or follow study procedures
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Investigated drugs

APG777 is an investigational medication being studied for the treatment of atopic dermatitis (also known as eczema). It is being tested for long-term use in patients with moderate to severe atopic dermatitis who have previously received treatment with this medication. The purpose is to understand how safe and effective the medication is when used over an extended period of time.

What is already known about the treatment

APG777 - An investigational medication being studied for the treatment of moderate-to-severe atopic dermatitis (also known as eczema), which is a chronic inflammatory skin condition. While the specific administration form is not publicly disclosed in current medical literature, the drug is undergoing clinical trials to evaluate its long-term safety and efficacy in patients who have previously received APG777 treatment. The medication belongs to a new class of therapeutic agents targeting inflammatory pathways involved in atopic dermatitis, though its exact molecular mechanism of action is still under investigation through ongoing clinical trials. This experimental drug represents a potential new treatment option for patients with persistent atopic dermatitis who may need long-term management of their condition.

Investigated diseases

Atopic Dermatitis - A chronic inflammatory skin condition that causes itchy, red, swollen, and cracked skin. The condition typically begins in early childhood but can occur at any age, often appearing in cycles of flare-ups and periods of improvement. It is characterized by intense itching, which can lead to scratching and further skin damage, creating a cycle known as the itch-scratch cycle. The condition commonly affects areas like the face, hands, feet, and the bends of elbows and knees. Atopic dermatitis is part of the "atopic triad," which means it often occurs alongside asthma and hay fever. The condition can be triggered by various factors including stress, allergens, irritants, and changes in temperature or humidity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519795-11-00Protocol codeAPG777-202Estimated enrolment446 patientsSponsorApogee Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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