A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
NCT ID: NCT06307626
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
105 participants
INTERVENTIONAL
2024-03-28
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/NCT06307613).
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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American Institute of Research
Los Angeles, California, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Cockerham Eye Consultants
San Diego, California, United States
Sibia Eye Institute
Boynton Beach, Florida, United States
Sarasota Retina Institute (SRI)
Sarasota, Florida, United States
Butchertown Clinical Trials
Louisville, Kentucky, United States
St. Louis University (SLU) Care - Center for Specialized Medicine
St Louis, Missouri, United States
Advancing Research International, LLC
Las Vegas, Nevada, United States
New York Eye & Ear Infirmary
New York, New York, United States
Baylor College of Medicine
Houston, Texas, United States
Landeskrankenhaus - Universitaetskliniken Innsbruck
Innsbruck, , Austria
Hanusch-Krankenhaus - Vienna Institute for Research in Ocular Surgery
Vienna, , Austria
AIPSMAED Sveti Luka EOOD
Plovdiv, , Bulgaria
Multi-Profile Hospital for Active Treatment (MHAT) Hadji Dimitar
Sliven, , Bulgaria
Medical Center Hera EOOD
Sofia, , Bulgaria
Military Medical Academy (MMA)
Sofia, , Bulgaria
Peking University Third Hospital
Beijing, , China
The Second Affiliated Hospital of Chengdu Medical College / Nuclear Industry 416 Hospital
Chengdu, , China
The Second Hospital of Dalian Medical University
Dalian, , China
Fujian Provincial Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Shandong Provincial Hospital of Shandong First Medical University
Jinan, , China
Hospices Civils de Lyon (HCL) - Hopital Louis Pradel
Bron, , France
CHU Lille - Hopital Huriez
Lille, , France
Centre Hospitalier National d'Ophtalmologie (Chno) Des Quinze-Vingts
Paris, , France
CHU de Saint-Etienne - Hopital Nord
Saint-Priest-en-Jarez, , France
JSC Curatio
Tbilisi, , Georgia
National Institute of Endocrinology
Tbilisi, , Georgia
New Hospitals
Tbilisi, , Georgia
Caucasus Medical Centre
Tbilisi, , Georgia
Universitaetsklinikum Essen (AoR)
Essen, , Germany
Klinikum Der Albert-Ludwigs Universitaet Freiburg
Freiburg im Breisgau, , Germany
Philipps-Universitaet Marburg Universitaetsklinikum Giessen und Marburg Klinik fuer Augenheilkunde
Marburg, , Germany
Universitaetsaugenklinik Ulm
Ulm, , Germany
Universita degli Studi di Cagliari - Ospedale San Giovanni di Dio
Cagliari, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, , Italy
Ospedale Cisanello
Pisa, , Italy
Azienda Ospedaliero Universitaria Sant'Andrea
Roma, , Italy
Azienda Ospedaliero Ordine Mauriziano Torino - Ospedale Umberto I di Torino
Torino, , Italy
Kanazawa University Hospital
Kanazawa, , Japan
Hospital of University of Occupational and Environmental Health
Kitakyushu, , Japan
Shinkoga clinic
Kurume, , Japan
Koga Hospital Group - Shinkoga Hospital
Kurume-shi, , Japan
National Hospital Organization Kyoto Medical Center
Kyoto, , Japan
Kozawa Eye Hospital and Diabetes Center
Mito, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Osaka City General Hospital
Osaka, , Japan
Hokkaido University Hospital
Sapporo, , Japan
Tohoku Medical and Pharmaceutical University - Fukumuro
Sendai, , Japan
Tottori University Hospital
Yonago, , Japan
Daugavpils Regionala Slimnica
Daugavpils, , Latvia
Paula Stradina Kliniska universitates slimnica
Riga, , Latvia
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Centrum Medycyny Inwazyjnej
Gdansk, , Poland
Szpital Sw. Rozy
Krakow, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Centrum Zdrowia MDM
Warsaw, , Poland
Clinical Center Vojvodina
Novi Sad, , Serbia
OLHB d.o.o.
Ljubljana, , Slovenia
University Medical Centre University Eye Hospital
Ljubljana, , Slovenia
Institut Catala de Retina (ICR) Centre Oftalmologic - ICR Seu Central Ganduxer
Barcelona, , Spain
Hospital La Arruzafa
Córdoba, , Spain
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Eye Clinic Linkoping
Linköping, , Sweden
Universitaetsspital Bern - Inselspital
Bern, , Switzerland
ADMEDICO Augenzentrum AG
Olten, , Switzerland
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Kocaeli University Research and Training Hospital
Kocaeli, , Turkey (Türkiye)
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, , United Kingdom
Royal Liverpool University Hospital , St Paul's Eye Unit - Liverpool University Hospitals NHS Foundation Trust
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Western Eye Hospital - Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Related Links
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US website
Other Identifiers
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2023-509198-22-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2309
Identifier Type: -
Identifier Source: org_study_id
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