Table of contents
- Trial overview
- Who can participate
- What is being measured
- Study design and phase
- Trial status and size
- Key patient terms
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.[1] The study is designed to see whether the treatment can improve eye bulging, also called proptosis, and to assess safety in the trial setting.[1]
The trial is listed as authorised, which means it has been approved to move forward in the study process.[1]
Who can participate
The trial includes participants who are 18 to 80 years of age and have thyroid eye disease.[1] This means the study is focused on adults rather than children or teenagers.[1]
The source data does not list more detailed entry rules, so the full participation criteria are not available here.[1]
What is being measured
The main outcome is the percentage of participants achieving proptosis response at Week 20.[1] 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.[1]
This kind of endpoint helps researchers understand both the size of the change and whether the improvement is stable enough to avoid extra treatment.[1]
Study design and phase
This is an interventional study, which means participants receive a study treatment so researchers can compare outcomes.[1] It is a Phase 2 trial, a stage that usually looks more closely at whether a treatment may work while continuing to monitor safety.[1]
The study compares subcutaneous TOUR006 with placebo.[1] Subcutaneous means the treatment is given under the skin.[1]
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.[1]
Trial status and size
The trial has a planned enrollment of 81 participants.[1] This gives a sense of the study size, although the source does not show how many people have already joined.[1]
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.[1]
Key patient terms
Proptosis means the eye bulges forward more than usual.[1]
Placebo means a comparison treatment that does not contain the active study medicine.[1]
Rescue therapy means extra treatment if the study treatment is not enough.[1]
Week 20 is the time point when the main result is checked in this study.[1]
