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Thyroid eye disease drug trial halted after early results disappoint

NCT ID NCT06307626

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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 105 adults were randomly assigned to receive either the drug or a placebo as a shot under the skin. The trial was stopped early because a planned check of the data showed the drug was unlikely to work well enough. No safety concerns were found.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efgartigimod PH20 SC (a drug given as a shot under the skin)
What this could lead to
If it had worked, this could have pointed toward a new treatment for thyroid eye disease, reducing bulging eyes and improving quality of life.
What could go wrong
The trial was stopped early because early results suggested it was unlikely to work as hoped. This was not due to safety issues, but the drug may not help this condition.

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

105 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.

Contacts and locations

Locations

  • ADMEDICO Augenzentrum AG

    Olten, 4600, Switzerland

  • AIPSMAED Sveti Luka EOOD

    Plovdiv, 4000, Bulgaria

  • Advancing Research International, LLC

    Las Vegas, Nevada, 89144, United States

  • American Institute of Research

    Los Angeles, California, 90017, United States

  • Azienda Ospedaliero Ordine Mauriziano Torino - Ospedale Umberto I di Torino

    Torino, 10128, Italy

  • Azienda Ospedaliero Universitaria Sant'Andrea

    Roma, 00189, Italy

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • CHU Lille - Hopital Huriez

    Lille, 59000, France

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270, France

  • Caucasus Medical Centre

    Tbilisi, 0186, Georgia

  • Centre Hospitalier National d'Ophtalmologie (Chno) Des Quinze-Vingts

    Paris, 75012, France

  • Centrum Medycyny Inwazyjnej

    Gdansk, 80-952, Poland

  • Centrum Zdrowia MDM

    Warsaw, 04-736, Poland

  • Clinical Center Vojvodina

    Novi Sad, 21000, Serbia

  • Cockerham Eye Consultants

    San Diego, California, 91208, United States

  • Daugavpils Regionala Slimnica

    Daugavpils, 5417, Latvia

  • Eye Clinic Linkoping

    Linköping, 581 85, Sweden

  • Fujian Provincial Hospital

    Fuzhou, 350001, China

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Hanusch-Krankenhaus - Vienna Institute for Research in Ocular Surgery

    Vienna, 1140, Austria

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hospices Civils de Lyon (HCL) - Hopital Louis Pradel

    Bron, 69677, France

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital La Arruzafa

    Córdoba, 14012, Spain

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, 08915, Spain

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, 807-8555, Japan

  • Institut Catala de Retina (ICR) Centre Oftalmologic - ICR Seu Central Ganduxer

    Barcelona, 08022, Spain

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

    Milan, 20132, Italy

  • JSC Curatio

    Tbilisi, 0114, Georgia

  • Kanazawa University Hospital

    Kanazawa, 920-8641, Japan

  • Klinikum Der Albert-Ludwigs Universitaet Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Kocaeli University Research and Training Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Koga Hospital Group - Shinkoga Hospital

    Kurume-shi, 830-8577, Japan

  • Kozawa Eye Hospital and Diabetes Center

    Mito, 310-0845, Japan

  • Landeskrankenhaus - Universitaetskliniken Innsbruck

    Innsbruck, 6020, Austria

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670, United States

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Memorial Ankara Hospital

    Ankara, 06520, Turkey (Türkiye)

  • Military Medical Academy (MMA)

    Sofia, 1606, Bulgaria

  • Moorfields Eye Hospital

    London, EC1V 2PD, United Kingdom

  • Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar

    Sliven, 8800, Bulgaria

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-0861, Japan

  • National Institute of Endocrinology

    Tbilisi, 0159, Georgia

  • New Hospitals

    Tbilisi, 0162, Georgia

  • New York Eye & Ear Infirmary

    New York, New York, 10003, United States

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520, Japan

  • North Valley Eye Medical Group, Inc.

    Mission Hills, California, 91345, United States

  • OLHB d.o.o.

    Ljubljana, 1000, Slovenia

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Ospedale Cisanello

    Pisa, 56124, Italy

  • Paula Stradina Kliniska universitates slimnica

    Riga, 1002, Latvia

  • Peking University Third Hospital

    Beijing, 100191, China

  • Philipps-Universitaet Marburg Universitaetsklinikum Giessen und Marburg Klinik fuer Augenheilkunde

    Marburg, 35043, Germany

  • Royal Liverpool University Hospital , St Paul's Eye Unit - Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP, United Kingdom

  • Sarasota Retina Institute (SRI)

    Sarasota, Florida, 34239, United States

  • Shandong Provincial Hospital of Shandong First Medical University

    Jinan, 250021, China

  • Shinkoga clinic

    Kurume, 830-8522, Japan

  • Sibia Eye Institute

    Boynton Beach, Florida, 33437, United States

  • St. Louis University (SLU) Care - Center for Specialized Medicine

    St Louis, Missouri, 63104, United States

  • Szpital Sw. Rozy

    Krakow, 30-394, Poland

  • The Second Affiliated Hospital of Chengdu Medical College / Nuclear Industry 416 Hospital

    Chengdu, 610066, China

  • The Second Hospital of Dalian Medical University

    Dalian, 116021, China

  • Tohoku Medical and Pharmaceutical University - Fukumuro

    Sendai, 983-8536, Japan

  • Tottori University Hospital

    Yonago, 683-8504, Japan

  • Universita degli Studi di Cagliari - Ospedale San Giovanni di Dio

    Cagliari, 09124, Italy

  • Universitaetsaugenklinik Ulm

    Ulm, 89075, Germany

  • Universitaetsklinikum Essen (AoR)

    Essen, 45147, Germany

  • Universitaetsspital Bern - Inselspital

    Bern, 3010, Switzerland

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS13NU, United Kingdom

  • University Medical Centre University Eye Hospital

    Ljubljana, 1000, Slovenia

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-355, Poland

  • Western Eye Hospital - Imperial College Healthcare NHS Trust

    London, NW1 5QH, United Kingdom

More trials for these conditions

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