Study of Efgartigimod for Adults with Thyroid Eye Disease

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What is this study about?

This clinical trial is focused on studying Thyroid Eye Disease (TED), a condition often associated with autoimmune thyroid disorders like Graves’ disease or Hashimoto’s thyroiditis. The study will evaluate a treatment called Efgartigimod, which is administered as a solution for injection using a pre-filled syringe. Efgartigimod is a type of protein designed to interact with the immune system, specifically targeting a receptor known as FcRn. The trial will compare the effects of Efgartigimod with a placebo to understand its effectiveness and safety.

The purpose of the study is to assess how well Efgartigimod works in reducing symptoms of Thyroid Eye Disease, particularly focusing on the reduction of eye bulging, known as proptosis, over a 24-week period. Participants in the study will receive either Efgartigimod or a placebo through subcutaneous injections, which means the injection is given under the skin. The study will monitor changes in eye symptoms and overall quality of life during this time.

Participants will be adults diagnosed with active, moderate-to-severe Thyroid Eye Disease. The study will involve regular visits to monitor the effects of the treatment and ensure the safety and well-being of the participants. The trial aims to provide valuable information on whether Efgartigimod can be a beneficial treatment option for those affected by this condition.

1 joining the study

Upon joining the study, the participant must be at least 18 years old and have a diagnosis of active, moderate-to-severe thyroid eye disease (TED) associated with autoimmune thyroid conditions.

The participant must have experienced the onset of active TED symptoms within 12 months before joining the study and have normal thyroid function or mild thyroid issues that are under control.

2 initial assessment

An initial assessment will be conducted to confirm eligibility, including a review of medical history and a physical examination.

Participants of child-bearing potential will undergo a blood pregnancy test at screening and a urine pregnancy test before receiving the study drug.

3 treatment period

The treatment involves receiving efgartigimod or a placebo, administered as a solution for injection using a pre-filled syringe.

The medication is given subcutaneously, which means it is injected under the skin.

The treatment period is double-blind, meaning neither the participant nor the study team knows whether the participant is receiving efgartigimod or the placebo.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate the efficacy and safety of the treatment.

The primary goal is to assess the percentage of participants who are proptosis responders at week 24 of the treatment period.

5 completion of treatment

At the end of the 24-week treatment period, final assessments will be conducted to measure changes in proptosis and quality of life scores.

The study aims to determine the effectiveness of efgartigimod in reducing symptoms of thyroid eye disease.

Who Can Join the Study?

  • The participant is at least 18 years old.
  • The participant is capable of providing signed informed consent, which means they understand the study and agree to participate, and can follow the study’s requirements.
  • The participant has a doctor’s diagnosis of active, moderate-to-severe Thyroid Eye Disease (TED), which is related to autoimmune thyroid conditions like Graves’ disease or Hashimoto’s thyroiditis, affecting the most severely impacted eye.
  • The participant has experienced symptoms of active TED within 12 months before the screening for the study.
  • The participant must have normal thyroid function, meaning their thyroid is working properly, or have mild hypothyroidism (underactive thyroid) or hyperthyroidism (overactive thyroid) at the time of screening. Efforts should be made to correct any mild thyroid issues quickly and maintain normal thyroid function throughout the study.
  • The participant agrees to use birth control as per local regulations. People who can have children must have a negative blood pregnancy test at screening and a negative urine pregnancy test before receiving the study drug.

Who Cannot Join the Study?

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had recent surgery or plan to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have received certain treatments for Thyroid Eye Disease (TED) recently.
  • Patients with uncontrolled high blood pressure or diabetes.
  • Patients with certain eye conditions that are not related to TED.
  • Patients who have a history of certain types of cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
University Medicine Greifswald Greifswald Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Spitalul Clinic Judetean De Urgenta Sf. Spiridon Iasi Iasi Romania
Oftex s.r.o. Pardubice Czechia
Nozologen Kft. Pecs Hungary
Medical Center Vereya EOOD Stara Zagora Bulgaria
Sana Monitoring S.R.L. Bucharest Romania
National Institute Of Endocrinology C.I. Parhon Bucharest Romania
University Teaching Hospital Markusovszky Szombathely Hungary
Bürgerhospital Frankfurt am Main – Clementine Kinderhospital Frankfurt Germany
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Tartu University Hospital Tartu Estonia
Fakultni Nemocnice Brno Brno Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
General University Hospital Of Patras Patras Greece
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
St. Luke’s Hospital S.A. Thessaloniki Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
University Of Pecs Pecs Hungary
Universita’ Degli Studi Di Ferrara Ferrara Italy
University Childrens Hospital Queen Fabiola Brussels Belgium
Budapest Retina Associates Budapest Hungary
Cjbmlxbrl Uyglrwwwlndjuw Sjnarbsvs Woluwe-Saint-Lambert Belgium
Axoq Cxekwvug skdyol Prague Czechia
Vrollky Kqwt Eger Hungary
Mtdfstf Crkyqt Owtogn Oah Burgas Bulgaria
Lpeod Geetibr Hftwqycv Oi Auoqfv Athens Greece
Axzk Mj Kbpeisru Varna Bulgaria
Uxbsmoqwgkcglvslvugtc Mtrcpzcn Ado Munster Germany
Aubqjl Mqgiike Ckfszv Sfkc Thessaloniki Greece
Ldjos Vxibat Od Paernu Estonia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.10.2024
Bulgaria Bulgaria
Not recruiting
01.10.2024
Czechia Czechia
Not recruiting
01.10.2024
Estonia Estonia
Not recruiting
01.10.2024
Germany Germany
Not recruiting
01.10.2024
Greece Greece
Not recruiting
01.10.2024
Hungary Hungary
Not recruiting
01.10.2024
Italy Italy
Not recruiting
01.10.2024
Romania Romania
Not recruiting
01.10.2024
Spain Spain
Not recruiting
01.10.2024

Trial locations

Investigated drugs:

Efgartigimod PH20 SC is a medication being studied for its effectiveness in treating Thyroid Eye Disease. It is administered using a prefilled syringe. The trial aims to assess how well this medication works, its safety, how the body processes it, and its potential to cause an immune response.

Investigated diseases:

Thyroid Eye Disease (TED) – This is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes, often associated with thyroid disorders. It leads to inflammation and swelling, causing the eyes to bulge outward, a condition known as proptosis. Patients may experience redness, irritation, and discomfort in the eyes, along with double vision or vision changes. As the disease progresses, it can lead to further complications such as restricted eye movement and eyelid retraction. The severity of symptoms can vary, and the disease may have periods of activity and inactivity. TED is often linked to Graves’ disease, but it can occur in other thyroid conditions as well.

Trial ID:
2023-509197-35-00
Protocol code:
ARGX-113-2301
NCT ID:
NCT06307613
Trial Phase:
Therapeutic confirmatory (Phase III)

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