A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
NCT ID: NCT06307613
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
102 participants
INTERVENTIONAL
2024-03-27
2026-03-31
Brief Summary
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After the screening period, eligible participants will be randomized in a 2:1 ratio to receive efgartigimod PH20 SC or placebo PH20 SC, respectively during the double-blinded treatment period (DBTP). At the end of the DBTP, participants may enter a follow-up observational period while off study drug. Some participants may also enter the open-label treatment period with efgartigimod PH20 SC. The study duration varies from approximately 60 to 110 weeks.
An alternative list of clinical sites open for recruitment could be found in the other UplighTED study record (https://www.clinicaltrials.gov/study/NCT06307626).
This study was terminated early on 15 December 2025 as the pre-defined interim analysis concluded that continuing the trials is unlikely to demonstrate the intended efficacy. This decision is not related to safety concerns, and the safety profile of efgartigimod remains unchanged. End-of-study and Safety-Follow-Up visits are ongoing for the participants of this trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Efgartigimod arm
Participants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo arm
Participants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Placebo PH20 SC
Subcutaneous placebo given by prefilled syringe
Interventions
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Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
Subcutaneous placebo given by prefilled syringe
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Thrive Health - Beverly Hills
Beverly Hills, California, United States
UCI Health - Gavin Herbert Eye Institute
Irvine, California, United States
University Of Southern California - Keck School Of Medicine
Los Angeles, California, United States
Silkiss Eye Surgery
San Francisco, California, United States
Advanced Research LLC
Coral Springs, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
University of South Florida (USF) Health - Morsani Center for Advanced Healthcare
Tampa, Florida, United States
University of Illinois Chicago
Chicago, Illinois, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
University of Michigan
Ann Arbour, Michigan, United States
Moyes Eye Center - Northland
Kansas City, Missouri, United States
Quest Diagnostics - Mercy Smith Glynn Callaway
Springfield, Missouri, United States
Duke University
Durham, North Carolina, United States
Penn Medicine - Penn Presbyterian Medical Center - Scheie Eye Institute
Philadelphia, Pennsylvania, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Centre for Eye Research Australia
Melbourne, , Australia
The University of Western Australia - Lions Eye Institute (LEI)
Nedlands, , Australia
North Shore Private Hospital
St Leonards, , Australia
Sydney Eye Hospital
Sydney, , Australia
CHU UVC Brugmann - Site Victor Horta
Brussels, , Belgium
Oxycom Medical Centre
Burgas, , Bulgaria
UMHAT Aleksandrovska - Diagnostic Consultative Center (DCC) Aleksandrova
Sofia, , Bulgaria
Medical Center Vereya EOOD - Vereya Medical Center (former Military Hospital)
Stara Zagora, , Bulgaria
St. Petka Eye Hospital - Eye Clinic St. Petka Varna
Varna, , Bulgaria
Peking Union Medical College Hospital - Dongdan campus
Beijing, , China
Shunde Hospital of Southern Medical University
Foshan, , China
Fujian Medical University Union Hospital
Fuzhou, , China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, , China
The Second Hospital of Anhui Medical University
Hefei, , China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Shanghai Ninth People's Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, , China
The First Hospital of China Medical University
Shenyang, , China
Fakultni Nemocnice Olomouc - Ocni Klinika
Olomouc, , Czechia
OFTEX - Ocni klinika
Pardubice, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Axon Clinical s.r.o
Prague, , Czechia
Dr Liina Viitas Endokrinoloog
Pärnu, , Estonia
Tartu Ulikooli Kliinikum
Tartu, , Estonia
Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
Buergerhospital Frankfurt am Main
Frankfurt, , Germany
Universitaetsklinikum der Ernst-Moritz-Arndt-Universitaet Greifswald
Greifswald, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
General Hospital of Athens G Gennimatas
Athens, , Greece
University General Hospital of Patras
Pátrai, , Greece
A.LOUKAS General Hospital of Thessaloniki
Thessaloniki, , Greece
Athens Medical Group - European Interbalkan Medical Center
Thessaloniki, , Greece
Budapest Retina Intezet
Budapest, , Hungary
Vadnay Szemeszet es Latszereszet
Eger, , Hungary
Ganglion Orvosi Kozpont
Pécs, , Hungary
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) University of Pecs Medical School
Pécs, , Hungary
Markusovszky Teaching Hospital
Szombathely, , Hungary
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano
Milan, , Italy
ASST Santi Paolo e Carlo - Ospedale San Paolo
Milan, , Italy
Azienda Ospedaliera Universitaria (AOU) Federico II
Naples, , Italy
Santa Chiara Hospital
Pisa, , Italy
ASST Sete Laghi - Ospedale di Circolo e Fondazione Macchi di Varese
Varese, , Italy
Centrul Medical Sana
Bucharest, , Romania
Institutul National de Endocrinologie C.I.Parhon
Bucharest, , Romania
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Spiridon
Iași, , Romania
National University Hospital
Singapore, , Singapore
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, , Spain
Hospital Clinico Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Faculty of Medicine Siriraj Hospital, Mahidol University
Bang Phlat, , Thailand
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, , United Kingdom
Cardiff and Vale University Health Board - University Hospital of wales (UHW)
Cardiff, , United Kingdom
Frimley Health NHS Foundation Trust - Frimley Park Hospital
Frimley, , United Kingdom
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, , United Kingdom
Countries
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Related Links
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US website
Other Identifiers
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2023-509197-35-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2301
Identifier Type: -
Identifier Source: org_study_id
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