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Study on Batoclimab for Patients with 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 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.

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 treatment administration

Receive Batoclimab, a solution for injection, administered subcutaneously.

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

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 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 Study?

  • 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 Study?

  • 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.

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
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Hospital General Universitario Gregorio Maranon Madrid Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University Hospital Bratislava Bratislava Slovakia
ARNAS Garibaldi Di Catania Catania Italy
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Nozologen Kft. Pecs Hungary
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Fakultna Nemocnica Trencín Trencin Slovakia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Universita’ Di Pisa Pisa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o. Poznan Poland
University Of Pecs Pecs Hungary
Budapest Retina Associates Budapest Hungary
Cbgkxjlxp Urhvzhmuptjass Subglvyug Woluwe-Saint-Lambert Belgium
Zqeqyruwfhucpf ribieyzos sawwkhxp Szi Ventspils Latvia
Dozgr Tqboicgdcjz aamhl puetsx eoyvuvocntqvurz Scq Ogre Latvia
Ubagnjfesww nbtjoqtux &nswnto Nniiaqdcz ssuiqdn Miaxpsty as s Bratislava Slovakia
Coaihmh Mvdmqtep Hona Clrztc Lublin Poland
Rrfgt Arkxhdab kytibhay uasmfsitbylnu sgrofzcm Skb Riga Latvia
Nhvczuaa Ieredoeg Omrjxmqin Idc Mttpa Shvjkfcivuqwrvsootwhqbzqwgsx Iafxnfdw Bzpsbnsc Cracow Poland
Axizaob Udbnq Sbwjswzai Lffpyn Dz Bgjignb Bologna Italy
Ikxhbnzmi Dv Mwkvkbnqyriv Okcqui Dfq Szcl Barcelona Spain
Uxxuedarzi Dbnke Shohr Dy Rotz Lv Sxgrnzij Rome Italy
Citkfja Avx Cihvth Barcelona Spain
Ootyhrx Sfl z oagi Lublin Poland
Ilgsv Opipxafa Ayolvbwdkl Sqi Lpaw Milan Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.04.2023
Hungary Hungary
Not recruiting
30.04.2023
Italy Italy
Not recruiting
30.04.2023
Latvia Latvia
Not recruiting
30.04.2023
Poland Poland
Not recruiting
30.04.2023
Slovakia Slovakia
Not recruiting
30.04.2023
Spain Spain
Not recruiting
30.04.2023

Trial locations

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.

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 ID:
2024-512650-21-00
Protocol code:
IMVT-1401-3203
Trial Phase:
Therapeutic confirmatory (Phase III)

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