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Study on Batoclimab for Treating Patients with Active Thyroid Eye Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Thyroid Eye Disease (TED). This is a condition where the muscles and tissues around the eyes become inflamed, leading to symptoms such as bulging eyes, discomfort, and vision problems. The study is testing a treatment called Batoclimab, which is given as a solution for injection under the skin. Batoclimab is also known by other names, including IMVT-1401, RVT-1401, HL161BKN, and HBM9161. The purpose of the study is to evaluate how effective Batoclimab is in treating people with active Thyroid Eye Disease.

Participants in the study will receive Batoclimab injections once a week for a total of 24 weeks. For the first 12 weeks, the dose will be 680 mg, and for the following 12 weeks, the dose will be reduced to 340 mg. Some participants will receive a placebo, which looks like the treatment but does not contain any active substance. The study aims to see if Batoclimab can help reduce the bulging of the eyes, known as proptosis, and improve other symptoms of Thyroid Eye Disease by the end of the 24-week period.

The study will monitor changes in eye symptoms and overall quality of life for participants. It will also look at how the treatment affects certain antibodies in the blood that are related to Thyroid Eye Disease. The goal is to determine if Batoclimab can provide significant relief from the symptoms of this condition compared to the placebo. Participants will be closely observed throughout the study to ensure their safety and to gather information on the treatment’s effectiveness.

1 initial treatment phase

The study begins with the administration of batoclimab at a dose of 680 mg. This is given as a subcutaneous injection, which means it is injected under the skin.

The injection is administered once a week for a duration of 12 weeks.

2 dose adjustment phase

Following the initial 12 weeks, the dose of batoclimab is adjusted to 340 mg.

This adjusted dose is also administered as a subcutaneous injection once a week for another 12 weeks.

3 placebo administration

During the study, some participants may receive a placebo instead of batoclimab. The placebo is identical in appearance to the active medication but contains no active substance.

The administration schedule for the placebo follows the same pattern as the active medication: once a week for 24 weeks.

4 evaluation of treatment response

The primary goal of the study is to assess the response to treatment at Week 24. This involves measuring the reduction in eye protrusion (proptosis) by at least 2 mm in the treated eye without worsening in the other eye.

Secondary assessments include changes in clinical activity score (CAS), eye movement, and quality of life related to eye health.

Who Can Join the Study?

  • Must be at least 18 years old at the time of screening.
  • Have a clinical diagnosis of Thyroid Eye Disease (TED), which is a condition affecting the eyes.
  • Have active, moderate to severe TED with a Clinical Activity Score (CAS) of 4 or more in either eye. CAS is a way to measure how active the disease is.
  • Show signs of worsened proptosis, which means the eyes are bulging. This includes having proptosis of 18 mm or more, or an increase of 3 mm or more from before the TED diagnosis.
  • Have moderate to severe active TED as defined by specific guidelines from a group of experts called the European Group on Graves’ Orbitopathy (EUGOGO).
  • The TED must have started within 12 months before the screening.
  • Have documented evidence of detectable anti-TSHR-Ab at screening. This is a specific antibody related to the condition.
  • Should not need immediate surgery and should not plan to have surgery, radiation, or other medical treatments for TED during the study.
  • Must be euthyroid, meaning their thyroid levels are normal, or have mild hypothyroidism (low thyroid levels) or hyperthyroidism (high thyroid levels) that is under control.

Who Cannot Join the Study?

  • Patients who have a different eye condition other than Thyroid Eye Disease (TED) cannot participate. TED is a condition where the eyes are affected due to thyroid problems.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may not be safe for them or their babies.
  • Patients who are currently participating in another clinical trial cannot participate, as this might affect the results of the study.
  • Patients who have had recent surgery or plan to have surgery during the study period cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate, as this might interfere with the study results.
  • Patients who have allergies to the study medication or its ingredients cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach Katowice Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
ARNAS Garibaldi Di Catania Catania Italy
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Bürgerhospital Frankfurt am Main – Clementine Kinderhospital Frankfurt Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Universita’ Di Pisa Pisa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
Omavjpo Sis z oftb Lublin Poland
Czqxrsw Mkmeovcc Hsga Cqhlch Lublin Poland
Nfbiywpy Ieogkrtd Olcyhglby Ifu Mtkrq Slgufjwgsubbcrkqkjrdnyifpzxa Iauhgbgv Biucahak Cracow Poland
Aqeaiwl Uejft Sclwvdira Lieegr Dk Bjrrrnl Bologna Italy
Ubfyjhdprw Dryik Siski Dn Rpua Ls Srpjikmp Rome Italy
Itnye Olnwivqg Admdgxwpio Sjl Lmis Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
23.11.2022
Italy Italy
Not recruiting
23.11.2022
Poland Poland
Not recruiting
23.11.2022

Trial locations

Investigated drugs:

Batoclimab: This medication is being studied for its potential to treat people with active Thyroid Eye Disease (TED). It is administered through an injection under the skin. The trial aims to see how effective Batoclimab is in reducing the symptoms of TED, specifically focusing on the improvement of eye protrusion, which is a common issue in this condition.

Investigated diseases:

Thyroid Eye Disease (TED) – This is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes, leading to inflammation and swelling. It often occurs in people with thyroid disorders, particularly Graves’ disease. The disease can cause symptoms such as bulging eyes, redness, and discomfort. As it progresses, it may lead to double vision and difficulty moving the eyes. The severity of symptoms can vary, and they may fluctuate over time. TED can significantly impact the appearance and function of the eyes, affecting daily activities.

Trial ID:
2024-512648-45-00
Protocol code:
IMVT-1401-3201
Trial Phase:
Therapeutic confirmatory (Phase III)

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