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Study of the safety and effectiveness of TRIV-573 injections in adults with moderate to severe atopic dermatitis

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What is this trial about?

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

Atopic dermatitis is a long‑lasting skin condition that causes red, itchy, and inflamed patches. The study examines a new medicine called TRIV-573, which is given as a subcutaneous injection (an injection under the skin), and compares it with a placebo.

The purpose of the study is to assess how well TRIV-573 improves the skin of people with moderate to severe atopic dermatitis. Participants are randomly assigned to receive either the study drug or the placebo, receive the injection at several visits, and are followed for a period of time to see changes in their skin condition.

During the study, safety is closely watched by checking for any side effects, measuring vital signs such as blood pressure, and performing routine blood tests. Researchers also look for the body’s response to the drug, including any antibodies that might develop, to ensure the treatment is both safe and effective.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    After joining the study you will be assigned, in a blinded manner, to receive either TRIV-573 or placebo. You will not know which treatment you receive.

  2. Step 2

    Baseline Assessments

    A study staff member will record your medical history, the severity of your atopic dermatitis (AD), vital signs, an electrocardiogram (ECG), and will take blood samples for safety laboratory tests.

  3. Step 3

    First Injection

    You will receive the first dose of the assigned medication by subcutaneous (SC) injection, which means the injection is given under the skin. The dose is 00 mg of a solution for injection.

  4. Step 4

    Follow‑up Visits and Additional Injections

    You will return to the study site at scheduled intervals. During each visit you will undergo safety checks, including vital signs, ECG, and laboratory tests, and you will receive additional doses of the same medication by SC injection according to the study schedule.

  5. Step 5

    Ongoing Safety Monitoring

    At every visit any side effects, known as treatment‑emergent adverse events (TEAEs), will be recorded. Serious adverse events (SAEs) will be reported immediately. Changes in vital signs, ECG results, physical examination findings, and laboratory values will be evaluated.

  6. Step 6

    Final Assessment

    At the end of the treatment period a comprehensive evaluation will be performed. This includes measuring the percentage of improvement in your atopic dermatitis, checking for anti‑TRIV‑573 antibodies, and reviewing all safety data collected during the study.

  7. Step 7

    Study Completion

    After the final assessment the study participation ends for you. All data collected will be used to determine the efficacy and safety of TRIV-573 compared with placebo.

Who can join the trial?

4 criteria

  • Be between 18 and 75 years old and have a doctor‑diagnosed case of atopic dermatitis that is moderate to severe (the rash is clearly noticeable and causes problems), active (present now), chronic (lasting for a long time), and symptomatic (producing symptoms such as itching or redness).
  • Weigh at least 40 kg (about 88 pounds) when screened for the study.
  • Agree to follow all study instructions and avoid taking certain other medicines during the trial.
  • Not have experienced a significant recent flare (a sudden worsening) of your atopic dermatitis.

Who cannot join the trial?

3 criteria

  • If you have severe or uncontrolled medical conditions (serious health problems that are not well managed with treatment), you cannot join the study.
  • If you have a known chronic liver disease (a long‑lasting problem with the liver), you are not eligible.
  • If you are currently using a non‑biological investigational product or device (a new medicine or medical tool that is not made from living cells and is still being tested), you cannot participate.
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Investigated drugs

TRIV-573 is an experimental medicine being studied to see if it can improve the skin condition of people with moderate to severe atopic dermatitis. In the trial, it is given as a sterile liquid that is injected just under the skin (subcutaneous injection). Researchers are looking at how well it works to reduce itching and rash, how safe it is for participants, and how the body absorbs and processes the drug over time.

What is already known about the treatment

TRIV-573 - TRIV-573 is given as a subcutaneous injection of a sterile solution for injection. It is an experimental drug currently in Phase 2 clinical trials and is not yet approved for general medical use. It is being studied for the treatment of moderate to severe atopic dermatitis, a chronic skin inflammation. The drug works by blocking the interleukin‑31 receptor, reducing the signals that cause itching and skin inflammation, and it belongs to the class of biologic agents that target cytokine receptors.

Investigated diseases

Atopic dermatitis - Atopic dermatitis is a chronic skin condition that causes red, itchy, and inflamed patches. It often begins in early childhood and may continue into adulthood. The rash can spread to larger areas of the body and become thicker and more scaly over time. Flare‑ups can be triggered by irritants, allergens, or changes in temperature, leading to periods of worsening symptoms followed by calmer phases.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526485-25-00Protocol code573-101Estimated enrolment90 patientsSponsorTriveni Bio Inc.

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