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New drug aims to reduce bulging eyes in thyroid disease

NCT ID NCT05987423

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

131 people

The number who actually took part.

Started

Oct 2023

Finished

Jun 2026

Lead sponsor

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

Anyone

Healthy volunteers

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

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.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 'Northwell Health Physician Partners Ophthalmology

    Great Neck, New York, 11021, United States

  • A.O. U. Federico II

    Naples, Campania, 80131, Italy

  • Aichi Medical University Hospital

    Aichi, 480-1195, Japan

  • Austin Retina Associates

    Austin, Texas, 78705-1169, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124, Italy

  • Budapest Retina Associates Kft.

    Budapest, 1133, Hungary

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002, Australia

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425, Argentina

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1015ABO, Argentina

  • Centrovision Mendoza

    Mendoza, M5500BWG, Argentina

  • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353, Germany

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Eyelid Center of Utah

    Salt Lake City, Utah, 84102, United States

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, Italy

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168, Italy

  • Great Lakes Eye Care

    Saint Joseph, Michigan, 49085, United States

  • Grene Vision Group, LLC

    Wichita, Kansas, 67206, United States

  • Grupo Laser Vision

    Rosario, S2000DLA, Argentina

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hong Kong Eye Hospital

    Mong Kok, Hong Kong

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8556, Japan

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Kobe Kaisei Hospital Medical foundation

    Hyōgo, 657-0068, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Medizinische Universitat Wien

    Vienna, 1090, Austria

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-8555, Japan

  • National University Hospital

    Singapore, 119074, Singapore

  • Oftalmos

    Capital Federal, C1120AAN, Argentina

  • Olympia Eye Hospital

    Tokyo, 150-0001, Japan

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586, Japan

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, Lombardy, 21100, Italy

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Singapore Eye Research Institute

    Singapore, 168751, Singapore

  • Social Medical Corporation Tenjinkai Shinkoga Hospital

    Fukuoka, 830-8577, Japan

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000, Australia

  • Thrive Health Research LLC

    Beverly Hills, California, 90210, United States

  • UCSD Shiley Eye Center

    La Jolla, California, 92093-0946, United States

  • Universitatsklinikum Munster

    Münster, 48149, Germany

  • University of Michigan, Kellogg Eye Center

    Ann Arbor, Michigan, 48105, United States

  • University of Miyazaki Hospital

    Miyazaki, 889-1692, Japan

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

    Dresden, 01307, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106, Germany

  • WVU Eye Institute

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.