In short
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.
Key points
- Clinical trial data for HUMANISED IGG1 KAPPA MONOCLONAL ANTIBODY AGAINST THYMIC STROMAL LYMPHOPOIETIN focus on atopic dermatitis, a skin condition that causes itchy and inflamed skin. The study was a Phase 2 interventional trial planned for 96 participants with moderate-to-severe disease. It compared the study drug with placebo. The main endpoint was the percent change in EASI score at Week 24, which measures eczema severity. The trial status was Withdrawn, so it did not reach completion.
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. The study was designed to compare the treatment with placebo, which is an inactive treatment used for comparison.
This trial was planned as a Phase 2 study with 96 participants. The study title says it was meant to evaluate both efficacy and safety in atopic dermatitis.
Study design and population
The study was interventional, meaning researchers assigned a study treatment and then measured the results. The target population was patients with moderate-to-severe AD, which means people with more serious disease rather than mild symptoms.
The trial record lists one active study drug arm and one placebo arm. 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.
Main outcome being measured
The primary outcome was the percent change from baseline in EASI score at Week 24. EASI stands for Eczema Area and Severity Index, a score used to measure how severe eczema is.
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. A percent change shows how much the score improved or worsened compared with the starting point.
Trial status and meaning
The trial status was Withdrawn. This means the study was stopped before completion, so the planned research did not finish as intended.
Because the trial was withdrawn, the record does not provide completed results for the main outcome. The available information is still useful because it shows what the study was trying to measure and who it was meant to study.
Patient-friendly terms
Atopic dermatitis is a long-term skin condition that can cause itchy, red, and inflamed skin. 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.
Safety means how well a treatment is tolerated and whether it causes problems in the study setting. Efficacy means how well a treatment works against the disease being studied.