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HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN

Clinical trials are investigating HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN in people with atopic dermatitis. These studies aim to assess safety and efficacy, including changes in disease severity. The trial data here focus on patients with moderate-to-severe atopic dermatitis.

Table of contents

Trial overview

The available trial record describes an interventional study of HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN in atopic dermatitis, also called AD.[1] The study was designed to compare the treatment with placebo, which is an inactive treatment used for comparison.[1]

This trial was planned as a Phase 2 study with 96 participants.[1] The study title says it was meant to evaluate both efficacy and safety in atopic dermatitis.[1]

Study design and population

The study was interventional, meaning researchers assigned a study treatment and then measured the results.[1] The target population was patients with moderate-to-severe AD, which means people with more serious disease rather than mild symptoms.[1]

The trial record lists one active study drug arm and one placebo arm.[1] The intervention list names ATI-045 given subcutaneously and placebo to ATI-045, but the record does not provide more detail about dose schedules beyond the listed 600 mg subcutaneous dose.[1]

Main outcome being measured

The primary outcome was the percent change from baseline in EASI score at Week 24.[1] EASI stands for Eczema Area and Severity Index, a score used to measure how severe eczema is.[1]

Baseline means the starting point before treatment begins, and Week 24 means the outcome was planned to be checked after 24 weeks of study follow-up.[1] A percent change shows how much the score improved or worsened compared with the starting point.[1]

Trial status and meaning

The trial status was Withdrawn.[1] This means the study was stopped before completion, so the planned research did not finish as intended.[1]

Because the trial was withdrawn, the record does not provide completed results for the main outcome.[1] The available information is still useful because it shows what the study was trying to measure and who it was meant to study.[1]

Patient-friendly terms

Atopic dermatitis is a long-term skin condition that can cause itchy, red, and inflamed skin.[1] In this study, researchers wanted to see whether HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN could improve the skin condition compared with placebo.[1]

Safety means how well a treatment is tolerated and whether it causes problems in the study setting.[1] Efficacy means how well a treatment works against the disease being studied.[1]

Trial ID Phase Condition studied Status Enrollment
2024-520302-19-00 Phase 2 Atopic dermatitis Withdrawn 96

FAQ

  • What condition is being studied in these trials? The trial data focus on atopic dermatitis, also called AD. This is a long-term skin condition that can cause itchy and inflamed skin.
  • Who was planned to take part? The study was planned for patients with moderate-to-severe atopic dermatitis. The trial record does not give more detail about age or other entry rules.
  • What was the main goal of the study? The main goal was to compare HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN with placebo. The study looked at whether it could improve eczema severity and whether it was safe.
  • What phase was this trial? This was a Phase 2 trial. Phase 2 studies usually look at early signs that a treatment may work and continue to collect safety data.
  • Was the trial completed? No. The trial status was Withdrawn, which means it was stopped before it was completed.

Ongoing Clinical Trials on HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN

  • Study to evaluate ATI-045 injection compared to placebo in adults with moderate to severe atopic dermatitis

    Not yet recruiting

    2 1
    Investigated drugs:
    Czechia Germany Poland

Glossary

  • Atopic dermatitis: A common skin disease that causes dry, itchy, red, and inflamed skin.
  • AD: Short form for atopic dermatitis.
  • Moderate-to-severe: A level of disease that is more serious than mild disease and may affect daily life more strongly.
  • Placebo: An inactive treatment used for comparison in a study.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Phase 2: A trial stage that checks early evidence of benefit and continues safety testing.
  • EASI score: A score used to measure how severe eczema is. Lower scores usually mean less severe disease.
  • Baseline: The starting point before treatment begins.
  • Percent change: How much a score or number goes up or down, shown as a percentage.
  • Withdrawn: A trial status meaning the study was stopped before it was finished.

References