Study of 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 Thyroid Eye Disease (TED), a condition that affects the eyes and is often associated with thyroid problems. The study will evaluate a treatment called Batoclimab, which is a solution for injection. Batoclimab is also known by other names such as RVT-1401, HL161BKN, and HBM9161. The purpose of the study is to assess the effectiveness of Batoclimab in treating individuals with active TED.

Participants in the study will receive Batoclimab through a subcutaneous injection, which means it is injected under the skin. The treatment will be administered once a week for a total of 24 weeks. For the first 12 weeks, participants will receive a dose of 680 mg, followed by a reduced dose of 340 mg for the remaining 12 weeks. Some participants will receive a placebo, which looks like the treatment but does not contain the active substance.

The study aims to observe changes in the condition of the eyes, specifically looking at the reduction in eye protrusion, known as proptosis, by the end of the 24-week period. The trial will also monitor other aspects of the disease, such as changes in eye inflammation and overall eye health. The goal is to determine if Batoclimab can effectively improve symptoms of TED compared to the placebo.

1 initial treatment phase

Receive a subcutaneous injection of batoclimab at a dose of 680 mg once a week.

This phase lasts for 12 weeks.

2 maintenance treatment phase

Continue receiving subcutaneous injections of batoclimab, but the dose is reduced to 340 mg once a week.

This phase also lasts for 12 weeks.

3 placebo comparison

Some participants will receive a placebo instead of batoclimab. The placebo is identical in appearance but contains no active substance.

The purpose is to compare the effects of batoclimab with no active treatment.

4 evaluation of results

The main goal is to assess the reduction in proptosis (eye bulging) at Week 24.

A successful response is defined as a reduction of at least 2 mm in the affected eye without worsening in the other eye.

5 additional assessments

Secondary outcomes include changes in Clinical Activity Score (CAS), which measures the severity of symptoms.

Other assessments include changes in diplopia (double vision) and quality of life scores.

Who Can Join the Study?

Must be at least 18 years old at the time of screening.
Must have a clinical diagnosis of Thyroid Eye Disease (TED), which is a condition affecting the eyes, with active, moderate to severe symptoms. This includes a Clinical Activity Score (CAS) of 4 or more in either eye, and signs of worsened proptosis. Proptosis means the eyes are bulging out more than usual, with measurements of 18 mm or more, or an increase of 3 mm or more from before the TED diagnosis.
Must 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 active TED symptoms must have started within 12 months before the screening.
Must have documented evidence of detectable anti-TSHR-Ab, which are specific antibodies related to TED, at the time of screening.
Should not need immediate surgery and should not be planning any corrective surgery, radiation, or medical treatment for TED during the study period.
Must have a stable thyroid condition, meaning the thyroid hormone levels are normal (euthyroid) or only mildly low (hypothyroidism) or high (hyperthyroidism).

Who Cannot Join the Study?

Patients who have a different eye condition other than Thyroid Eye Disease cannot participate. Thyroid Eye Disease is a condition where the muscles and tissues around the eyes become swollen.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing or able to follow the study procedures cannot participate. This means they must be able to attend all appointments and follow instructions given by the study team.
Patients who have other serious health conditions that might interfere with the study cannot participate. This is to ensure the safety of the participants and the accuracy of the study results.
Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference with the results of the current study.
Patients who are allergic to the study medication or any of its ingredients cannot participate. This is to prevent any allergic reactions during the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
University Hospital Bratislava	Bratislava	Slovakia
Nozologen Kft.	Pecs	Hungary
Fakultna Nemocnica Trencín	Trencin	Slovakia
Bürgerhospital Frankfurt am Main – Clementine Kinderhospital	Frankfurt	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
University Of Pecs	Pecs	Hungary
Budapest Retina Associates	Budapest	Hungary
Chkhrllqu Uovrxpsruhpahg Sqeuithxh	Woluwe-Saint-Lambert	Belgium
Zftkpqhzftatis rwlbdktea sfoufsow Skb	Ventspils	Latvia
Diqbv Tyotyfclybv afgea pjecud elfblyvdmqaldni Sjo	Ogre	Latvia
Czrpytf Abc Cxtuvr	Barcelona	Spain
Upcpvgwxxlf ncpkbfzxq &hvihsy Nslfzanup sxoilwq Matsoswr an s	Bratislava	Slovakia
Roifa Ajomilpl klqwhynf uvmxcdawbjnqj sbjbwkfe Sey	Riga	Latvia
Ivcaotzuc Dn Mauxxujteuco Oxiygg Dlo Soso	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	05.01.2023
Germany	Not recruiting	05.01.2023
Hungary	Not recruiting	05.01.2023
Latvia	Not recruiting	05.01.2023
Slovakia	Not recruiting	05.01.2023
Spain	Not recruiting	05.01.2023

Trial locations

Investigated drugs:

Batoclimab

Batoclimab is a medication being studied for its potential to treat people with active Thyroid Eye Disease (TED). In this clinical trial, it is administered through an injection under the skin. The study 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.

Thyroid Eye Disease – This condition is an autoimmune disorder that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, commonly seen in Graves’ disease. The disease can cause symptoms such as bulging eyes, redness, swelling, and discomfort. As it progresses, individuals may experience double vision and difficulty moving the eyes. The severity of symptoms can vary, and they may fluctuate over time. In some cases, the disease can lead to changes in vision due to pressure on the optic nerve.

Trial ID:

2024-512649-18-00

Protocol code:

IMVT-1401-3202

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Batoclimab for Treating Patients with Active Thyroid Eye Disease

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