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Study on Batoclimab for Patients with Thyroid Eye Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Thyroid Eye Disease (TED), a condition that affects the eyes and is often associated with thyroid problems. The treatment being tested in this study is called Batoclimab, which is a solution for injection. Batoclimab is also known by other names such as IMVT-1401, RVT-1401, HL161BKN, and HBM9161. The purpose of the study is to assess how well Batoclimab maintains its effectiveness in treating TED, particularly by observing changes in eye protrusion, a common symptom of the disease.

Participants in this study have previously completed another study involving Batoclimab. This extension study allows researchers to continue monitoring the effects of the treatment over a longer period. The study involves regular injections of Batoclimab and periodic assessments to track the progress of the treatment. Participants will not undergo any immediate surgical interventions or other medical therapies for TED during the study period.

The study aims to understand how long the positive effects of Batoclimab last after stopping the treatment and to evaluate the proportion of participants who respond to the treatment. This information will help determine the long-term benefits and safety of Batoclimab for individuals with Thyroid Eye Disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after completing the Week 24 visit of the previous study.

    Eligibility requires no immediate need for surgery or other treatments for Thyroid Eye Disease (TED) during the study.

  2. Step 2

    Treatment administration

    Receive Batoclimab, a solution for injection, administered subcutaneously.

    The frequency and dosage are determined by the study protocol and medical team.

  3. Step 3

    Monitoring and assessments

    Regular assessments are conducted to monitor the response to treatment, focusing on changes in eye protrusion (proptosis).

    Evaluations occur at specified intervals, including a key assessment at Week 24.

  4. Step 4

    Completion of study

    The study is estimated to conclude by June 30, 2025.

    Final assessments will determine the duration of response after stopping treatment.

Who can join the trial?

5 criteria

  • Participants must have completed the Week 24 visit of the previous study they were part of.
  • Participants in the Open-label Treatment Group should not need immediate surgery or plan to have surgery, radiation, or other medical treatments for **Thyroid Eye Disease (TED)** during the study.
  • Participants in the Open-label Treatment Group must not have permanently stopped taking the study medication.
  • Both men and women can participate in the study.
  • The study includes people from vulnerable populations, which means groups that might need extra protection or care.

Who cannot join the trial?

4 criteria

  • Patients who have a different eye condition other than Thyroid Eye Disease (TED) cannot participate. TED is a condition that affects the eyes and is related to thyroid problems.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
  • Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.
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Investigated drugs

Batoclimab is a medication being studied for its effectiveness and safety in treating Thyroid Eye Disease (TED). This trial is an extension study for participants who have completed previous studies. The main goal is to see how well Batoclimab maintains its effectiveness in reducing eye bulging, a common symptom of TED.

What is already known about the treatment

Batoclimab – Batoclimab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its effectiveness in treating Thyroid Eye Disease (TED). The medication works by targeting and inhibiting specific proteins involved in the immune response, which helps reduce inflammation and symptoms associated with TED. Batoclimab is classified as a monoclonal antibody, a type of medication designed to interact with specific molecules in the body to modulate the immune system.

Investigated diseases

Thyroid Eye Disease (TED) – Thyroid Eye Disease is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes. This leads to inflammation and swelling, causing symptoms such as bulging eyes, redness, and discomfort. As the disease progresses, it can result in increased pressure within the eye socket, affecting eye movement and vision. The condition is often associated with thyroid disorders, particularly Graves' disease. Over time, the inflammation may lead to scarring and changes in the appearance of the eyes. The severity and progression of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512650-21-00Protocol codeIMVT-1401-3203Estimated enrolment180 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

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