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Thyroid eye disease drug trial halted early – no safety concerns

NCT ID NCT06307613

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called efgartigimod for people with active, moderate-to-severe thyroid eye disease, a condition that causes bulging eyes and vision problems. About 102 adults took part, receiving either the drug or a placebo. The trial was stopped early because early results showed it was unlikely to work well enough, though no safety issues were found.

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

102 people

The number who actually took part.

Started

Mar 2024

Finished

Feb 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: * The participant is at least 18 years of age * The participant is capable of providing signed informed consent and following with protocol requirements * The investigator determines active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions (Graves' disease or Hashimoto's thyroiditis) for the most severely affected eye * The participant has first onset of active TED symptoms within 12 months before screening * The participant must have normal thyroid function with the baseline disease under control or have mild hypo or hyperthyroidism at screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the normal thyroid function for the full duration of the study * The participant agrees to use birth control consistent with local regulations and the people of child-bearing potential must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug Exclusion Criteria: * Optic neuropathy (damage to optic nerve), defined as new visual field defect (blind spot), relative afferent pupillary defect (pupils respond differently to light), or color defect secondary to optic nerve involvement within the 6 months before screening * Corneal decompensation (swelling of the cornea) unresponsive to medical management * Previous orbital irradiation or surgery for TED * Use of some medications before screening (more information is found in the protocol) * Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of TED or puts the participant at undue risk * History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer * Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV * Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and at least 1 dose of study drug received or has received at least 1 dose of commercially available efgartigimod * Known hypersensitivity to study drug or one of its excipients (inactive ingredients) * History of or current alcohol, drug, or medication abuse within 12 months before screening as assessed by the investigator * Pregnant or lactating state or intention to become pregnant during the study * Live or live-attenuated vaccine received \<4 weeks before screening The complete list of exclusion criteria can be found in the protocol.

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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.

Thyroid eye disease

Contacts and locations

Locations

  • A.LOUKAS General Hospital of Thessaloniki

    Thessaloniki, 55236, Greece

  • ASST Santi Paolo e Carlo - Ospedale San Paolo

    Milan, 20142, Italy

  • ASST Sete Laghi - Ospedale di Circolo e Fondazione Macchi di Varese

    Varese, 21100, Italy

  • Advanced Research LLC

    Coral Springs, Florida, 33067, United States

  • Athens Medical Group - European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Axon Clinical s.r.o

    Prague, 15000, Czechia

  • Azienda Ospedaliera Universitaria (AOU) Federico II

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134, Italy

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136, United States

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    Bradford, BD9 6RJ, United Kingdom

  • Budapest Retina Intezet

    Budapest, 1133, Hungary

  • Buergerhospital Frankfurt am Main

    Frankfurt, 60318, Germany

  • CHU UVC Brugmann - Site Victor Horta

    Brussels, 1020, Belgium

  • Cardiff and Vale University Health Board - University Hospital of wales (UHW)

    Cardiff, CF14 4XW, United Kingdom

  • Centre for Eye Research Australia

    Melbourne, 3002, Australia

  • Centrul Medical Sana

    Bucharest, 011025, Romania

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117, Germany

  • Dr Liina Viitas Endokrinoloog

    Pärnu, 80018, Estonia

  • Duke University

    Durham, North Carolina, 27705, United States

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bang Phlat, 10700, Thailand

  • Fakultni Nemocnice Olomouc - Ocni Klinika

    Olomouc, 77900, Czechia

  • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

    Milan, 20122, Italy

  • Frimley Health NHS Foundation Trust - Frimley Park Hospital

    Frimley, GU16 7UJ, United Kingdom

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Ganglion Orvosi Kozpont

    Pécs, 7621, Hungary

  • General Hospital of Athens G Gennimatas

    Athens, 11527, Greece

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15702, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Institutul National de Endocrinologie C.I.Parhon

    Bucharest, 011863, Romania

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330, Thailand

  • Levenson Eye Associates

    Jacksonville, Florida, 32204, United States

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 52000, Thailand

  • Markusovszky Teaching Hospital

    Szombathely, 9700, Hungary

  • Medical Center Vereya EOOD - Vereya Medical Center (former Military Hospital)

    Stara Zagora, 6008, Bulgaria

  • Moyes Eye Center - Northland

    Kansas City, Missouri, 64154, United States

  • National University Hospital

    Singapore, 119074, Singapore

  • North Shore Private Hospital

    St Leonards, 2065, Australia

  • OFTEX - Ocni klinika

    Pardubice, 53002, Czechia

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Oxycom Medical Centre

    Burgas, 8000, Bulgaria

  • Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) University of Pecs Medical School

    Pécs, 7624, Hungary

  • Peking Union Medical College Hospital - Dongdan campus

    Beijing, 100730, China

  • Penn Medicine - Penn Presbyterian Medical Center - Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104, United States

  • Quest Diagnostics - Mercy Smith Glynn Callaway

    Springfield, Missouri, 65807, United States

  • Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE1 4LP, United Kingdom

  • Santa Chiara Hospital

    Pisa, 56126, Italy

  • Shanghai Ninth People's Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, 200011, China

  • Shunde Hospital of Southern Medical University

    Foshan, 528399, China

  • Silkiss Eye Surgery

    San Francisco, California, 94102, United States

  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon

    Iași, 700111, Romania

  • Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila

    Bucharest, 10825, Romania

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • St. Petka Eye Hospital - Eye Clinic St. Petka Varna

    Varna, 9010, Bulgaria

  • Sydney Eye Hospital

    Sydney, 2000, Australia

  • Tartu Ulikooli Kliinikum

    Tartu, 50406, Estonia

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, 471003, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310003, China

  • The First Hospital of China Medical University

    Shenyang, 110002, China

  • The Second Hospital of Anhui Medical University

    Hefei, 230601, China

  • The University of Western Australia - Lions Eye Institute (LEI)

    Nedlands, 6009, Australia

  • Thrive Health - Beverly Hills

    Beverly Hills, California, 90210, United States

  • UCI Health - Gavin Herbert Eye Institute

    Irvine, California, 92697, United States

  • UMHAT Aleksandrovska - Diagnostic Consultative Center (DCC) Aleksandrova

    Sofia, 1431, Bulgaria

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum der Ernst-Moritz-Arndt-Universitaet Greifswald

    Greifswald, 17475, Germany

  • University General Hospital of Patras

    Pátrai, 26504, Greece

  • University Of Southern California - Keck School Of Medicine

    Los Angeles, California, 90033, United States

  • University of Illinois Chicago

    Chicago, Illinois, 60612, United States

  • University of Michigan

    Ann Arbour, Michigan, 48105, United States

  • University of South Florida (USF) Health - Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612, United States

  • Vadnay Szemeszet es Latszereszet

    Eger, 3300, Hungary

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 00, Czechia

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506, United States

  • Wilmer Eye Institute

    Baltimore, Maryland, 21205, United States

More trials for these conditions

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