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HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR

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.

Table of contents

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.[1] The study is in Phase 2, which means it is looking more closely at whether the treatment may help and continuing to monitor safety.[1]

Who is being studied

The trial is for participants with Graves’ disease and active thyroid eye disease.[1] Graves’ disease is an autoimmune condition, which means the body’s defense system attacks its own tissues.[1] The source does not give more detailed entry rules, such as age limits or other medical requirements.[1]

Trial design and treatment groups

The study compares HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR with placebo.[1] A placebo looks like the study treatment but does not contain the active study medicine, so researchers can compare results fairly.[1] 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.[1]

The intervention list includes K1-70 given as a 100 mg intravenous infusion and placebo to K1-70.[1] An intravenous infusion means the treatment is given through a vein.[1]

What the trial is measuring

The main outcome is the exophthalmos improvement rate at Week 24.[1] Exophthalmos means forward bulging of the eye.[1] 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.[1]

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.[1] The 24-week time point shows that the study is looking at treatment effect over several months, not just after a short time.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 50 participants, so this is a relatively small study designed to gather early evidence in a specific patient group.[1]

Patient-friendly glossary

  • Active thyroid eye disease: A stage where the eye disease is still active and symptoms may still change.[1]

  • Phase 2: A mid-stage trial that checks whether a treatment may work and continues to watch safety.[1]

  • Placebo: A look-alike treatment used for comparison.[1]

  • Enrollment: The number of people planned for the study.[1]

Trial ID Phase Condition studied Status Enrollment
2024-519292-26-00 Phase 2 Graves’ disease and active thyroid eye disease Authorised 50

FAQ

  • What is being studied in these trials? The trials are testing HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR in people with Graves’ disease and active thyroid eye disease. The main goal is to see whether it improves eye bulging better than placebo.
  • Who can take part in the study? The study is for participants with Graves’ disease and active thyroid eye disease. The trial data does not give more detailed entry rules in the source provided.
  • What phase is the trial? The study is a Phase 2 trial. Phase 2 trials usually look more closely at whether a treatment works and continue to check safety.
  • What condition is this trial focused on? This trial focuses on Graves’ disease and active thyroid eye disease. Thyroid eye disease is a condition that can cause the eyes to bulge forward.
  • What result is the study measuring? The main result is the exophthalmos improvement rate at Week 24. Exophthalmos means forward bulging of the eye, and the study checks whether the eye bulging improves by at least 2 mm without worsening in the other eye.

Ongoing Clinical Trials on HUMAN IGG1 MONOCLONAL ANTIBODY AGAINST THYROTROPIN RECEPTOR

  • Study of K1-70 compared to placebo for patients with active thyroid eye disease from Graves’ disease

    Recruiting

    2 1
    Investigated drugs:
    Italy Spain

Glossary

  • Graves’ disease: An autoimmune disease that affects the thyroid gland. Autoimmune means the body’s immune system attacks its own tissues.
  • Active thyroid eye disease: A stage of thyroid eye disease where the condition is still active and symptoms can still change.
  • Exophthalmos: Forward bulging of the eye. In this study, it is measured in millimeters.
  • Placebo: A treatment that looks like the study drug but has no active study medicine. It is used for comparison.
  • Phase 2: A trial stage that looks at whether a treatment may work and continues to study safety in a larger group than Phase 1.
  • Interventional study: A study where researchers give a treatment and then measure what happens.
  • Enrollment: The number of people planned to join the trial.
  • Intravenous infusion: A treatment given through a vein, usually by a needle or tube.
  • Primary outcome: The main result the trial is designed to measure.
  • Week 24: The time point 24 weeks after the start of treatment.

References

  1. https://clinicaltrials.gov/study/2024-519292-26-00