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HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7

Clinical trials are investigating HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7 in adults with moderate to severe atopic dermatitis. The studies aim to evaluate efficacy and safety, with outcomes measured after treatment. This article summarizes the trial purpose, phase, target population, and main endpoint.

Table of contents

Trial overview

The available trial is a study to investigate the efficacy and safety of HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7 compared with placebo in adults with moderate to severe atopic dermatitis.[1]

The study is described as an interventional trial, which means researchers assign a study treatment and then measure the results.[1]

Study design and treatment comparison

This trial compares TRIV-509 with a placebo, which is a look-alike treatment used for comparison.[1]

The brief summary says the study is assessing TRIV-509 given by subcutaneous injection for 12 weeks in adults with moderate to severe atopic dermatitis.[1]

The source also lists TRIV-509 placebo as the comparison treatment in the study.[1]

Who can participate

The trial is focused on adults with moderate to severe atopic dermatitis.[1]

No other participant rules are provided in the source data, so the available information only confirms the age group and the condition being studied.[1]

What the trial measures

The primary outcome is the percentage of participants with improvement of atopic dermatitis at Week 16.[1]

This means the study will measure how many people improved after treatment, using a specific time point in the study schedule.[1]

The trial summary also shows that the study aims to assess efficacy and safety, so both benefit and tolerability are part of the research goal.[1]

Trial status and size

The trial status is Authorised.[1]

It is a Phase 2 study with planned enrollment of 90 participants.[1]

Phase 2 trials usually help researchers learn more about whether a treatment may work while continuing to monitor safety, and this study fits that research stage.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522113-35-00 Phase 2 Atopic dermatitis Authorised 90

FAQ

  • What condition is being studied in the trial? The trial is studying atopic dermatitis, which is a long-term inflammatory skin condition. It focuses on adults with moderate to severe disease.
  • Who can take part in this trial? Adults with moderate to severe atopic dermatitis may be eligible. The trial data do not list more detailed selection rules.
  • What is the trial trying to find out? The main goal is to assess efficacy and safety of HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7. Efficacy means how well the treatment works, and safety means how well it is tolerated in the study.
  • What phase is the study? This is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment may work and continue checking safety.
  • What result is the trial measuring? The main result is the percentage of participants with improvement of atopic dermatitis at Week 16. This helps show how many people improved during the study period.

Ongoing Clinical Trials on HUMAN IGG1 BISPECIFIC MONOCLONAL ANTIBODY AGAINST KALLIKREIN-5 AND KALLIKREIN-7

  • A study testing TRIV-509 compared to placebo in adults with moderate to severe atopic dermatitis

    Not recruiting

    2 1
    Investigated drugs:
    Bulgaria Czechia Hungary Poland

Glossary

  • Atopic dermatitis: A common skin condition that causes inflammation, itching, and irritated skin. It can be mild, moderate, or severe.
  • Moderate to severe: A description of how serious a condition is. Moderate to severe means the symptoms are more than mild and may affect daily life.
  • Efficacy: How well a treatment works in a study.
  • Safety: How well a treatment is tolerated and whether it causes problems during the study.
  • Placebo: A look-alike treatment that does not contain the active study drug. It is used for comparison in some trials.
  • Interventional study: A study in which researchers give a treatment or intervention and then measure the results.
  • Phase 2: A stage of clinical research that studies whether a treatment may work and continues to monitor safety.
  • Subcutaneous injection: An injection given under the skin.
  • Enrollment: The number of participants planned for the study.
  • Primary outcome: The main result the trial is designed to measure.
  • Week 16: The study time point 16 weeks after the start of treatment.

References

  1. https://clinicaltrials.gov/study/2025-522113-35-00