In short
Clinical trials are studying HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR in people with Graves’ disease and active thyroid eye disease. These studies aim to compare how well it works and how safe it is, often against placebo. The main focus is on adults with active eye disease and changes in eye bulging.
Key points
- Clinical trials are studying HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR in people with Graves’ disease and active thyroid eye disease. The main trial listed is a Phase 2 study with 50 planned participants. It compares the study treatment with placebo over 24 weeks. The main outcome is whether eye bulging improves by at least 2 mm without worsening in the other eye. The trial is authorised and is focused on patients with active disease.
Trial overview
The available trial information describes one interventional study of HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR in people with Graves’ disease and active thyroid eye disease. The study is in Phase 2, which means it is looking more closely at whether the treatment may help and continuing to monitor safety.
Who is being studied
The trial is for participants with Graves’ disease and active thyroid eye disease. Graves’ disease is an autoimmune condition, which means the body’s defense system attacks its own tissues. The source does not give more detailed entry rules, such as age limits or other medical requirements.
Trial design and treatment groups
The study compares HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR with placebo. A placebo looks like the study treatment but does not contain the active study medicine, so researchers can compare results fairly. The brief summary says the treatment is given once every 6 weeks for 24 weeks, but the trial record also names the study drug as K1-70.
The intervention list includes K1-70 given as a 100 mg intravenous infusion and placebo to K1-70. An intravenous infusion means the treatment is given through a vein.
What the trial is measuring
The main outcome is the exophthalmos improvement rate at Week 24. Exophthalmos means forward bulging of the eye. The trial counts a response if the study eye improves by at least 2 mm and the other eye does not worsen by at least 2 mm.
This outcome is important because it focuses on a visible sign of active thyroid eye disease and checks whether the change is meaningful for the patient. The 24-week time point shows that the study is looking at treatment effect over several months, not just after a short time.
Trial status and size
The trial status is Authorised. The planned enrollment is 50 participants, so this is a relatively small study designed to gather early evidence in a specific patient group.
Patient-friendly glossary
- Active thyroid eye disease: A stage where the eye disease is still active and symptoms may still change.
- Phase 2: A mid-stage trial that checks whether a treatment may work and continues to watch safety.
- Placebo: A look-alike treatment used for comparison.
- Enrollment: The number of people planned for the study.