Promising drug may reduce eye bulging in thyroid disease
NCT ID NCT06106828
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests a drug called satralizumab in 127 people with moderate-to-severe thyroid eye disease, a condition that causes eye bulging and discomfort. Participants receive either the drug or a placebo to see if it reduces eye bulging by at least 2 millimeters over 24 weeks. The goal is to find a safer, non-surgical treatment option.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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127 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Clinical diagnosis of TED based on CAS Exclusion Criteria: * Decrease in CAS or proptosis of \>≥ 2 points or ≥ 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1) * Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator * Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study * Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548, Portugal
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Beijing Hospital of Ministry of Health
Beijing, 100730, China
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Beijing Tongren Hospital, Capital Medical University
Beijing, 100730, China
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Bristol Eye Hospital
Bristol, BS1 2LX, United Kingdom
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CHNO Hopital des Quinze Vingts
Paris, 75012, France
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CHU Nantes - Hotel Dieu
Nantes, 44093, France
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Chung-Ang University Hospital
Seoul, 06973, South Korea
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Connecticut Eye Consultants, P.C.
Danbury, Connecticut, 06810, United States
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Fondation Rothschild
Paris, 75019, France
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Gartnavel General Hospital
Glasgow, G12 0YN, United Kingdom
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Hadassah MC
Jerusalem, 9112001, Israel
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Hospital Ramon y Cajal
Madrid, 28031, Spain
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
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Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
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Hospital Universitario Vall d Hebron
Barcelona, 08035, Spain
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Hospital Universitario Virgen de la Macarena
Seville, 41007, Spain
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Hospital Universitario Virgen de las Nieves
Granada, 18012, Spain
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Hospital Universitario la Fe: Servicio de Oftalmologia
Valencia, 46026, Spain
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Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
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Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD, United Kingdom
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Peking Union Medical College Hospital
Beijing, 100032, China
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Peking University Third Hospital
Beijing, 100191, China
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Plastics-Orbit-Neuro
San Diego, California, 92108, United States
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Profesorskie Centrum Medyczne Spolka Z Ograniczona Odpowiedzialnoscia
Gdansk, 80-180, Poland
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Rabin MC
Petah Tikva, 4941492, Israel
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Retina Consultants of Texas
San Antonio, Texas, 78251, United States
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Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
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Samsung Medical Center
Seoul, 135-710, South Korea
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Scheie Eye Institute
Philadelphia, Pennsylvania, 19104, United States
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Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, 003-722, South Korea
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Sheba medical center
Ramat Gan, Israel
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Specjalistyczny Osrodek Okulistyczny Oculomedica
Bydgoszcz, 85-316, Poland
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St James University Hospital
Leeds, LS9 7TF, United Kingdom
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Sussex Eye Hospital
Brighton, BN2 5BF, United Kingdom
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Toronto Retina Institute
Toronto, Ontario, M3C 0G9, Canada
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Universite de Montreal - Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
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University of Alberta
Edmonton, Alberta, Canada
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University of Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
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Vanderbilt Eye Institute
Nashville, Tennessee, 37232-8808, United States
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Xi'an Fourth Hospital
Xi'an, 710004, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill tame thyroid eye disease?
- Can a targeted antibody calm thyroid eye disease?
- Could a cholesterol drug shrink eye muscle swelling in thyroid eye disease?
- Can an experimental drug reduce eye bulging in thyroid eye disease?
- Can a new drug ease bulging eyes in thyroid disease?
- New drug IBI3031 enters first human trial for thyroid eye disease