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
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.	Poznan	Poland
Nozologen Kft.	Pecs	Hungary
Cdllwhswz Ucnhdejquxkjki Srqlejwjv	Woluwe-Saint-Lambert	Belgium
Fqgjklcukj Iwayq Ct Gsvjzs Oaspvfby Mcztqace Pdoswozzzry	Milan	Italy
Uahfmyeirosu Dp Shawzsoi Db Cemffoboyg	Santiago De Compostela	Spain
Sysppalkucp Ppfbuprxe Zrkslj Osjrai Zqxxstqvcu Sqlfhbx Uipbcmsqelamx W Kwgtavyo	Cracow	Poland
Aimuxjv Objzzzqvcai Ubyhkhzomzsyl Fgvxnazj Ij Dj Nkquvq	Naples	Italy
Awgtbtw Ubktv Swzpywggs Lgbixw Dj Bragrtt	Bologna	Italy
Unejcxkumi Durpr Scovm Dg Rchu Lp Snunusoh	Rome	Italy
Clpnqo hpwsijydigs ujvrudowwskxw dn Lkziv	Liege	Belgium
Uvhmuwkulage Zbbiuhrmtr Gcer	Gent	Belgium
Frrrhcqx Neqwioqqx Txcypst	Trencin	Slovakia
Uebvlrqkdnmnbi Czhwzvq Kxdfsegzb Ihh Pkcth Ku Geetfnmvpaj Snebwganx Ungxmcnvymjx Mrmytcswes W Kwofliibfb	Katowice	Poland
Zlxlzmbildknlm rjnrnjidn stbovitf Szt	Ventspils	Latvia
Dutwt Tmjuqdkgpmy agoja pxccfd ennuwlwcmivpzag Snf	Ogre	Latvia
Cmbvxrd Abu Cvjmkd	Barcelona	Spain
Uxgfnhxtzba nondmyahg &qpbvbg Nghzegzdn sjvrkje Mnqimjbq av s	Bratislava	Slovakia
Oirtlxq Sca z owbx	Lublin	Poland
Cgdaibb Mgxbfuzx Hrsl Cevvyq	Lublin	Poland
Btzdtopg Rhbkzr Aokmmhfwpb	Budapest	Hungary
Uefffhzuzfypzmkvu Dl Pmuy	Pisa	Italy
Rmvpn Ainnmgia kjnbyqvs uwwageenqaols srvfquaz Sbz	Riga	Latvia
Nbxppwoe Ingpvfml Oibrhjvak Iix Mpzsh Sbrcinvgkdnevsxrubjrxzcxxqmv Ijxssbbs Brwtpbzz	Cracow	Poland
Unjjriftdp Ox Pomi	Pecs	Hungary
Ijlswxnbn Dd Mwcarwclsfdn Owsxcq Dwg Sszj	Barcelona	Spain
Ajrykev Ouctxvudusjtgwqotgsvpminu Sruk Aqcwy	Rome	Italy
Afkrcpn Ofuzoqbzect Ulehqayrktqhc Paxzvnemqpo Ptwjt Gcaawtod	Palermo	Italy
Urloorletu Hjkfkaye Bexnxpcfaw	Bratislava	Slovakia
Ayzah Gjnviuotg Da Cjlgbbu	Catania	Italy
Usycfvdanttfee Coeeglk Kihojfhnz Wnyureqyhxcco Uwmdgqflndif Moxcdyyeql	Warsaw	Poland
Wgucarbuqr Szsohcs Spzxamdstpanwmn W Otbibkoyg	Olsztyn	Poland
Ildma Oswmustp Allkbsuned Sqi Lmff	Milan	Italy

Trial status

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

Trial locations

Investigated Drugs:

Batoclimab

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:

Endocrine ophthalmopathy

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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Study on Batoclimab for Patients with Thyroid Eye Disease

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