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Thyroid Eye DiseasePhase 3UplighTEDNCT06307626

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 76 sites in 18 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
105 participants
Where
76 sitesin 18 countries
Study dates
28 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

76 sites in 18 countries.

76 sites in 18 countries

Japan12 sites

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • Hospital of University of Occupational and Environmental Health

    Kitakyushu, 807-8555

  • Shinkoga clinic

    Kurume, 830-8522

  • Koga Hospital Group - Shinkoga Hospital

    Kurume-shi, 830-8577

  • National Hospital Organization Kyoto Medical Center

    Kyoto, 612-0861

  • Kozawa Eye Hospital and Diabetes Center

    Mito, 310-0845

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Osaka City General Hospital

    Osaka, 534-0021

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku Medical and Pharmaceutical University - Fukumuro

    Sendai, 983-8536

  • Tottori University Hospital

    Yonago, 683-8504

Other trials in Japan

United States11 sites

  • Sibia Eye Institute

    Boynton Beach, Florida, 33437

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Advancing Research International, LLC

    Las Vegas, Nevada, 89144

  • American Institute of Research

    Los Angeles, California, 90017

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206

  • North Valley Eye Medical Group, Inc.

    Mission Hills, California, 91345

  • New York Eye & Ear Infirmary

    New York, New York, 10003

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Cockerham Eye Consultants

    San Diego, California, 91208

  • Sarasota Retina Institute (SRI)

    Sarasota, Florida, 34239

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

    St Louis, Missouri, 63104

Other trials in United States

China6 sites

  • Peking University Third Hospital

    Beijing, 100191

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

    Chengdu, 610066

  • The Second Hospital of Dalian Medical University

    Dalian, 116021

  • Fujian Provincial Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • Shandong Provincial Hospital of Shandong First Medical University

    Jinan, 250021

Other trials in China

Poland6 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Centrum Medycyny Inwazyjnej

    Gdansk, 80-952

  • Szpital Sw. Rozy

    Krakow, 30-394

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-355

  • Centrum Zdrowia MDM

    Warsaw, 04-736

Other trials in Poland

Italy5 sites

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

    Cagliari, 09124

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

    Milan, 20132

  • Ospedale Cisanello

    Pisa, 56124

  • Azienda Ospedaliero Universitaria Sant'Andrea

    Roma, 00189

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

    Torino, 10128

Other trials in Italy

Bulgaria4 sites

  • AIPSMAED Sveti Luka EOOD

    Plovdiv, 4000

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

    Sliven, 8800

  • Medical Center Hera EOOD

    Sofia, 1510

  • Military Medical Academy (MMA)

    Sofia, 1606

Other trials in Bulgaria

France4 sites

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

    Bron, 69677

  • CHU Lille - Hopital Huriez

    Lille, 59000

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

    Paris, 75012

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42270

Other trials in France

Georgia4 sites

  • JSC Curatio

    Tbilisi, 0114

  • National Institute of Endocrinology

    Tbilisi, 0159

  • New Hospitals

    Tbilisi, 0162

  • Caucasus Medical Centre

    Tbilisi, 0186

Other trials in Georgia

Germany4 sites

  • Universitaetsklinikum Essen (AoR)

    Essen, 45147

  • Klinikum Der Albert-Ludwigs Universitaet Freiburg

    Freiburg im Breisgau, 79106

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

    Marburg, 35043

  • Universitaetsaugenklinik Ulm

    Ulm, 89075

Other trials in Germany

Spain4 sites

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

    Barcelona, 08022

  • Hospital La Arruzafa

    Córdoba, 14012

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès, 08915

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

United Kingdom4 sites

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS13NU

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

    Liverpool, L7 8XP

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Western Eye Hospital - Imperial College Healthcare NHS Trust

    London, NW1 5QH

Other trials in United Kingdom

Austria2 sites

  • Landeskrankenhaus - Universitaetskliniken Innsbruck

    Innsbruck, 6020

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

    Vienna, 1140

Other trials in Austria

Latvia2 sites

  • Daugavpils Regionala Slimnica

    Daugavpils, 5417

  • Paula Stradina Kliniska universitates slimnica

    Riga, 1002

Other trials in Latvia

Slovenia2 sites

  • OLHB d.o.o.

    Ljubljana, 1000

  • University Medical Centre University Eye Hospital

    Ljubljana, 1000

Other trials in Slovenia

Switzerland2 sites

  • Universitaetsspital Bern - Inselspital

    Bern, 3010

  • ADMEDICO Augenzentrum AG

    Olten, 4600

Other trials in Switzerland

Turkey (Türkiye)2 sites

  • Memorial Ankara Hospital

    Ankara, 06520

  • Kocaeli University Research and Training Hospital

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Serbia1 site

  • Clinical Center Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Sweden1 site

  • Eye Clinic Linkoping

    Linköping, 581 85

Other trials in Sweden

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/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.

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 NCT06307626
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 start28 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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307626
Sponsor's protocol ID
ARGX-113-2309
Other IDs
2023-509198-22-00, 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 76 sites in 18 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 76 sites in Japan, United States, China, Poland, Italy and 13 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 NCT06307626.

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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