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Study on the Effects of Batoclimab for Patients with Graves' Disease

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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 Graves' disease, an immune system disorder that leads to the overproduction of thyroid hormones. The treatment being tested is called Batoclimab, also known by its code name IMVT-1401. Batoclimab is a solution for injection that is administered under the skin. The purpose of the study is to investigate how Batoclimab affects thyroid hormone levels in people with Graves' disease.

Participants in the study will receive Batoclimab injections over a period of 24 weeks. Throughout the study, the effects of the treatment on thyroid hormone levels will be monitored. The goal is to see if Batoclimab can help normalize these hormone levels without increasing the dose of other medications used to treat Graves' disease. The study will also look at whether participants can reduce or stop their other medications while maintaining normal hormone levels.

This study is open-label, meaning that both the participants and the researchers know which treatment is being administered. The trial aims to provide insights into the safety and effectiveness of Batoclimab for managing Graves' disease, potentially offering a new treatment option for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria, including being 18 years or older and having confirmed Graves' disease (GD).
Active hyperthyroidism due to GD must be present, with specific thyroid hormone levels at the screening visit.
Step 2
Initial treatment phase
Receive batoclimab, a solution for injection administered subcutaneously.
The treatment aims to assess the effects on thyroid hormone levels over a 24-week period.
Step 3
Monitoring and assessment
Regular monitoring of thyroid hormone levels, specifically FT3 and FT4, occurs throughout the study.
The primary goal is to achieve normalization of these hormone levels by Week 24 without increasing the dose of antithyroid drugs (ATD).
Step 4
Secondary objectives
Secondary goals include achieving hormone normalization with a reduced ATD dose or discontinuing ATD treatment while maintaining normal hormone levels.
Step 5
Completion of the study
The study is estimated to conclude by August 31, 2025.
Final assessments will determine the proportion of participants who meet the primary and secondary endpoints.

Who can join the trial?

9 criteria

Must be a male or female who is **18 years or older**.
Must have **Grave's disease** confirmed by a blood test showing high levels of a specific antibody called **TSH-R-Ab**.
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Must have **active hyperthyroidism** due to Grave's disease, which means having certain levels of thyroid hormones in the blood:
- **TSH** (a hormone that stimulates the thyroid) must be lower than normal.
- **FT3** (a type of thyroid hormone) must be higher than normal but not more than 5 times the upper limit of normal.
- **FT4** (another type of thyroid hormone) must be higher than normal but not more than 5 times the upper limit of normal.
- If the participant has a condition called **T3 thyrotoxicosis** (where TSH is low, FT3 is high, but FT4 is normal), they can still join if they have confirmed Grave's disease.
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  Must meet certain requirements related to **antithyroid drugs (ATD)** at the screening visit:
  - Must have been taking an ATD for at least **12 weeks** before the screening.
  - Must have started with a total daily dose of at least **20 mg** of methimazole or carbimazole, or at least **100 mg** of propylthiouracil.
  - Other specific criteria may apply as defined in the study protocol.

Who cannot join the trial?

8 criteria

Participants who have any other serious health condition that might interfere with the study.
Individuals who are currently pregnant or breastfeeding.
People who have had a recent major surgery or are planning to have surgery during the study period.
Participants who are taking certain medications that could affect the study results.
Individuals with a history of drug or alcohol abuse.
People who have participated in another clinical trial recently.
Participants who have an allergy or sensitivity to the study medication.
Individuals who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany

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Investigated drugs

Batoclimab is a medication being studied for its potential to help people with Graves' Disease, a condition that affects the thyroid gland. The trial aims to see if batoclimab can safely and effectively lower thyroid hormone levels in participants.

Batoclimab

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 potential use in treating Graves' disease, an autoimmune disorder affecting the thyroid. The medication works by targeting and inhibiting specific immune system components that contribute to the overproduction of thyroid hormones. Batoclimab is classified as an immunomodulatory agent, aiming to reduce thyroid hormone levels and alleviate symptoms associated with the disease.

Investigated diseases

Graves' Disease – Graves' disease is an autoimmune disorder that leads to the overproduction of thyroid hormones, a condition known as hyperthyroidism. The immune system mistakenly attacks the thyroid gland, causing it to enlarge and produce excessive hormones. This can result in symptoms such as rapid heartbeat, weight loss, increased appetite, and nervousness. Over time, the excess hormones can affect various body systems, leading to complications like eye problems and skin issues. The disease often progresses with periods of remission and exacerbation. It is more common in women and can occur at any age, but typically appears before the age of 40.