New drug aims to reduce bulging eyes in thyroid disease
NCT ID NCT05987423
First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This Phase 3 trial tests satralizumab, a drug that blocks IL-6, in 131 people with moderate-to-severe thyroid eye disease. The main goal is to see if it reduces eye bulging by at least 2 mm after 24 weeks. Participants receive either satralizumab or placebo injections, and researchers also check for improvements in double vision and eye pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- satralizumab
- What this could lead to
- If it works, this could provide a new treatment option to reduce eye bulging and pain in people with thyroid eye disease.
- What could go wrong
- This is still an early Phase 3 trial with only 131 participants. The drug may not work better than placebo, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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131 people
The number who actually took part.
- Started
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Oct 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
-
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.
Show the full entry requirements Hide the full entry requirements
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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'Northwell Health Physician Partners Ophthalmology
Great Neck, New York, 11021, United States
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A.O. U. Federico II
Naples, Campania, 80131, Italy
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Aichi Medical University Hospital
Aichi, 480-1195, Japan
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Austin Retina Associates
Austin, Texas, 78705-1169, United States
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Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56124, Italy
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Budapest Retina Associates Kft.
Budapest, 1133, Hungary
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Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE, Argentina
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Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
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Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425, Argentina
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Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1015ABO, Argentina
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Centrovision Mendoza
Mendoza, M5500BWG, Argentina
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Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353, Germany
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EyeHealth Northwest
Portland, Oregon, 97225, United States
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Eyelid Center of Utah
Salt Lake City, Utah, 84102, United States
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
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Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168, Italy
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Great Lakes Eye Care
Saint Joseph, Michigan, 49085, United States
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Grene Vision Group, LLC
Wichita, Kansas, 67206, United States
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Grupo Laser Vision
Rosario, S2000DLA, Argentina
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Hokkaido University Hospital
Hokkaido, 060-8648, Japan
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Hong Kong Eye Hospital
Mong Kok, Hong Kong
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Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, 807-8556, Japan
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Johns Hopkins University
Baltimore, Maryland, 21205, United States
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Kobe Kaisei Hospital Medical foundation
Hyōgo, 657-0068, Japan
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Kyushu University Hospital
Fukuoka, 812-8582, Japan
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Medizinische Universitat Wien
Vienna, 1090, Austria
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National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
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National University Hospital
Singapore, 119074, Singapore
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Oftalmos
Capital Federal, C1120AAN, Argentina
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Olympia Eye Hospital
Tokyo, 150-0001, Japan
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Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
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Ospedale Di Circolo E Fondazione Macchi
Varese, Lombardy, 21100, Italy
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Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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Singapore Eye Research Institute
Singapore, 168751, Singapore
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Social Medical Corporation Tenjinkai Shinkoga Hospital
Fukuoka, 830-8577, Japan
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Sydney Eye Hospital
Sydney, New South Wales, 2000, Australia
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Thrive Health Research LLC
Beverly Hills, California, 90210, United States
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UCSD Shiley Eye Center
La Jolla, California, 92093-0946, United States
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Universitatsklinikum Munster
Münster, 48149, Germany
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University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105, United States
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University of Miyazaki Hospital
Miyazaki, 889-1692, Japan
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Universitäts-Augenklinik Tübingen
Tübingen, 72076, Germany
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Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Dresden, 01307, Germany
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Universitätsklinikum Essen
Essen, 45147, Germany
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Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
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WVU Eye Institute
Morgantown, West Virginia, 26506, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new antibody help when thyroid eye disease comes back?
- 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?