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Thyroid Eye DiseasePhase 3UplighTEDNCT06307613

A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease

A Phase 3 study testing Efgartigimod PH20 SC in people with Thyroid Eye Disease, run by argenx at 77 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Eye Disease
What is being tested?
Efgartigimod PH20 SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
77 sitesin 16 countries
Study dates
27 Mar 2024to 12 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

77 sites in 16 countries.

77 sites in 16 countries

United States16 sites

  • University of Michigan

    Ann Arbour, Michigan, 48105

  • Wilmer Eye Institute

    Baltimore, Maryland, 21205

  • Thrive Health - Beverly Hills

    Beverly Hills, California, 90210

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • Advanced Research LLC

    Coral Springs, Florida, 33067

  • Duke University

    Durham, North Carolina, 27705

  • UCI Health - Gavin Herbert Eye Institute

    Irvine, California, 92697

  • Levenson Eye Associates

    Jacksonville, Florida, 32204

  • Moyes Eye Center - Northland

    Kansas City, Missouri, 64154

  • University Of Southern California - Keck School Of Medicine

    Los Angeles, California, 90033

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • West Virginia University Eye Institute

    Morgantown, West Virginia, 26506

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

    Philadelphia, Pennsylvania, 19104

  • Silkiss Eye Surgery

    San Francisco, California, 94102

  • Quest Diagnostics - Mercy Smith Glynn Callaway

    Springfield, Missouri, 65807

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

    Tampa, Florida, 33612

Other trials in United States

China8 sites

  • Peking Union Medical College Hospital - Dongdan campus

    Beijing, 100730

  • Shunde Hospital of Southern Medical University

    Foshan, 528399

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, 310003

  • The Second Hospital of Anhui Medical University

    Hefei, 230601

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

    Luoyang, 471003

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

    Shanghai, 200011

  • The First Hospital of China Medical University

    Shenyang, 110002

Other trials in China

Italy7 sites

  • Azienda Ospedaliero Universitaria Careggi

    Florence, 50134

  • Ospedale Policlinico San Martino

    Genova, 16132

  • Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano

    Milan, 20122

  • ASST Santi Paolo e Carlo - Ospedale San Paolo

    Milan, 20142

  • Azienda Ospedaliera Universitaria (AOU) Federico II

    Naples, 80131

  • Santa Chiara Hospital

    Pisa, 56126

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

    Varese, 21100

Other trials in Italy

Hungary5 sites

  • Budapest Retina Intezet

    Budapest, 1133

  • Vadnay Szemeszet es Latszereszet

    Eger, 3300

  • Ganglion Orvosi Kozpont

    Pécs, 7621

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

    Pécs, 7624

  • Markusovszky Teaching Hospital

    Szombathely, 9700

Other trials in Hungary

United Kingdom5 sites

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    Bradford, BD9 6RJ

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

    Cardiff, CF14 4XW

  • Frimley Health NHS Foundation Trust - Frimley Park Hospital

    Frimley, GU16 7UJ

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

    London, SE1 7EH

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

    Newcastle, NE1 4LP

Other trials in United Kingdom

Australia4 sites

  • Centre for Eye Research Australia

    Melbourne, 3002

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

    Nedlands, 6009

  • North Shore Private Hospital

    St Leonards, 2065

  • Sydney Eye Hospital

    Sydney, 2000

Other trials in Australia

Bulgaria4 sites

  • Oxycom Medical Centre

    Burgas, 8000

  • UMHAT Aleksandrovska - Diagnostic Consultative Center (DCC) Aleksandrova

    Sofia, 1431

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

    Stara Zagora, 6008

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

    Varna, 9010

Other trials in Bulgaria

Czechia4 sites

  • Fakultni Nemocnice Olomouc - Ocni Klinika

    Olomouc, 77900

  • OFTEX - Ocni klinika

    Pardubice, 53002

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 00

  • Axon Clinical s.r.o

    Prague, 15000

Other trials in Czechia

Germany4 sites

  • Charite Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117

  • Buergerhospital Frankfurt am Main

    Frankfurt, 60318

  • Universitaetsklinikum der Ernst-Moritz-Arndt-Universitaet Greifswald

    Greifswald, 17475

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Greece4 sites

  • General Hospital of Athens G Gennimatas

    Athens, 11527

  • University General Hospital of Patras

    Pátrai, 26504

  • A.LOUKAS General Hospital of Thessaloniki

    Thessaloniki, 55236

  • Athens Medical Group - European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Romania4 sites

  • Centrul Medical Sana

    Bucharest, 011025

  • Institutul National de Endocrinologie C.I.Parhon

    Bucharest, 011863

  • Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila

    Bucharest, 10825

  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon

    Iași, 700111

Other trials in Romania

Spain4 sites

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Clinico Universitario De Santiago De Compostela

    Santiago de Compostela, 15702

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Thailand4 sites

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bang Phlat, 10700

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 52000

  • Srinagarind Hospital

    Khon Kaen, 40002

Other trials in Thailand

Estonia2 sites

  • Dr Liina Viitas Endokrinoloog

    Pärnu, 80018

  • Tartu Ulikooli Kliinikum

    Tartu, 50406

Other trials in Estonia

Belgium1 site

  • CHU UVC Brugmann - Site Victor Horta

    Brussels, 1020

Other trials in Belgium

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease

This study aims to evaluate the efficacy, safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of efgartigimod PH20 SC in participants with active, moderate-to-severe TED, compared with placebo PH20 SC.

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.

Read more

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.

Being tested
Efgartigimod PH20 SC, Placebo PH20 SC
Medical subject headings
Graves Ophthalmopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Efgartigimod PH20 SCCombination product

    Subcutaneous efgartigimod PH20 SC given by prefilled syringe

  • Placebo PH20 SCOther

    Subcutaneous placebo given by prefilled syringe

Study groups in NCT06307613
Study groupRoleWhat they receive
Efgartigimod armExperimentalParticipants with active, moderate-to-severe TED receiving Efgartigimod PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Receives: Combination Product: Efgartigimod PH20 SC
Placebo armPlacebo comparatorParticipants with active, moderate-to-severe TED receiving Placebo PH20 SC (subcutaneously) via pre-filled syringe (PFS)
Receives: Other: Placebo PH20 SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who were proptosis responders

    Measured: At week 24 of the Double-Blinded Treatment Period

Secondary outcomes (3)

  1. Change in proptosis measurement in the study eye from baseline

    Measured: Up to week 24 of the Double-Blinded Treatment Period

  2. Change in the total Graves' Orbitopathy Quality of Life (GO-QoL) score from baseline

    Minimum value: 0 (most negative impact on Quality of Life); Maximum value: 100 (No impact on Quality of Life)

    Measured: Up to week 24 of the Double-Blinded Treatment Period

  3. Percentage of participants with a resolution of diplopia (responders)

    Measured: At week 24 of the Double-Blinded Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start27 Mar 2024
  3. Primary completion15 Dec 2025
  4. Study completion12 Feb 2026

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307613
Sponsor's protocol ID
ARGX-113-2301
Other IDs
2023-509197-35-00, 2023
Acronym
UplighTED
Status last verified
Mar 2026
First submitted
6 Mar 2024
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Efgartigimod PH20 SC in people with Thyroid Eye Disease, run by argenx at 77 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, China, Italy, Hungary, United Kingdom and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who were proptosis responders (time frame: At week 24 of the Double-Blinded Treatment Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06307613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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