In short
Clinical trials are studying HUMAN IGG2 MONOCLONAL ANTIBODY AGAINST IL-6 in people with thyroid eye disease. These studies look at safety and whether the treatment can improve eye symptoms, especially proptosis, which means the eye bulging forward. The trial data here includes adults 18 to 80 years old.
Key points
- Clinical trials of HUMAN IGG2 MONOCLONAL ANTIBODY AGAINST IL-6 are studying thyroid eye disease in adults 18 to 80 years old. The trial shown here is a Phase 2 interventional study with 81 planned participants. Researchers are comparing the study treatment with placebo to see whether it improves proptosis, which is eye bulging. The main outcome is the percentage of participants who achieve a proptosis response at Week 20. The response must happen without worsening in the other eye and without needing rescue treatment.
Trial overview
This clinical study is testing HUMAN IGG2 MONOCLONAL ANTIBODY AGAINST IL-6 in people with thyroid eye disease, a condition that can change the way the eyes look and feel. The study is designed to see whether the treatment can improve eye bulging, also called proptosis, and to assess safety in the trial setting.
The trial is listed as authorised, which means it has been approved to move forward in the study process.
Who can participate
The trial includes participants who are 18 to 80 years of age and have thyroid eye disease. This means the study is focused on adults rather than children or teenagers.
The source data does not list more detailed entry rules, so the full participation criteria are not available here.
What is being measured
The main outcome is the percentage of participants achieving proptosis response at Week 20. A proptosis response means the eye bulging improves by at least 2 mm in the study eye, while the other eye does not worsen by 2 mm or more and no rescue therapy or intervention is needed.
This kind of endpoint helps researchers understand both the size of the change and whether the improvement is stable enough to avoid extra treatment.
Study design and phase
This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes. It is a Phase 2 trial, a stage that usually looks more closely at whether a treatment may work while continuing to monitor safety.
The study compares subcutaneous TOUR006 with placebo. Subcutaneous means the treatment is given under the skin.
The intervention list also includes the formulation ingredients used with the study drug, but the trial record does not provide extra research goals for those ingredients.
Trial status and size
The trial has a planned enrollment of 81 participants. This gives a sense of the study size, although the source does not show how many people have already joined.
The condition studied is thyroid eye disease, and the trial brief summary says the purpose is to evaluate the efficacy of TOUR006 in reducing proptosis.
Key patient terms
- Proptosis means the eye bulges forward more than usual.
- Placebo means a comparison treatment that does not contain the active study medicine.
- Rescue therapy means extra treatment if the study treatment is not enough.
- Week 20 is the time point when the main result is checked in this study.