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

Other Sites

Site Name City Country Status
University Hospital Olomouc Olomouc Czechia
Nozologen Kft. Pecs Hungary
Cbydyzmqq Ukfdsgyqluhvcl Sogqrrkwx Woluwe-Saint-Lambert Belgium
Lwxgp Gcpwosj Htexmtqe Of Attlgu Athens Greece
Duyhkoudttfvrwwivvqvxhn cgucjc “vkpkgqxnyrnanif Ekuc Sofia Bulgaria
Fgajuirbum Ijshg Cl Gxdpch Oktrovia Mnhuaaiq Ppicddtdmtw Milan Italy
Cnfucbf Urhjrsxwdhnuyxgndleh Bgzgoe Kgr Berlin Germany
Fwbdmeui Ngefunjub Buik Brno Czechia
Iqzgc Oclxvfzg Pbeuqplwovk Sjx Mdrcepd Genoa Italy
Uzhdyzkgphrhzgfzbsvbn Mfxgcyfo Aaa Munster Germany
Aegdghy Ozifshqcahn Uufnbwxmhhxkr Fkgagjrp Im Dw Njdnqf Naples Italy
Gzrfuod Uzsttrhbnj Huqdihmk Ou Pgnofu Patras Greece
Ajyqni Mewkapb Cjzofq Suaq Thessaloniki Greece
Vadtavqwc Frzhukny Nqvdwqtyu V Pgpjj Prague Czechia
Hrwfjwag Uoygtwboflolk Pthgfl Dq Hznpzw Ds Mmwdeookzhs Majadahonda Spain
Ualtnlktqazieasgv Dukos Skbui Dl Fvgutqx Ferrara Italy
Arlcunk Savsl Sbrntlhhi Tvsniopzavjo Dgz Sdrgr Lspzk Varese Italy
Achs Cwltpbec spnbdh Prague Czechia
Cdexvud Ggohr Stdbyleh Santiago De Compostela Spain
Ulwrxpyknl Tksjqdfs Hwklbytq Mzhrymryeizo Szombathely Hungary
Avoi Mx Kiobrftu Varna Bulgaria
Swddezlb Cwngbl Jvrmyudz Dr Uknxgrc Svw Sgixclqq Imkn Iasi Romania
Vduqbbm Kuux Eger Hungary
Bsteanxzndcovj Fpevjvopa ap Muwc – Cxuarnqylp Kivhxrbayuuvqe Frankfurt Germany
Lpsik Vprhyx Oh Paernu Estonia
Bklvbfky Ruwxxa Avkpowdtpl Budapest Hungary
Tvwyf Ujqrkkkoau Hfknjjmk Tartu Estonia
Uyqvqunfstepjwees Da Pbry Pisa Italy
Akfkvxu Sfcvfjxwzapvhj Trmntaxyjadw Snalu Pmqbm E Cpesu Milan Italy
Sjvtayyv Ulzzoaytvpw Dz Uaquutl Mfmxnwp Cxtguyl Dtq Cgeuw Difvlq Bucharest Romania
Sqe Lguxfoamgfea Hissdbqw Sren Thessaloniki Greece
Uwtebpasuz Og Pwjo Pecs Hungary
Uyjhyhujzn Cvpczrnxu Hkynyyxs Qcldf Fiibzxv Brussels Belgium
Szfo Mceqlmtzkf Sboqvz Bucharest Romania
Oebpj scchos Pardubice Czechia
Nenxsxzp Ijlquajqc Ot Eytavowrpthoc Ctkl Ppkxtj Bucharest Romania
Mnpxxun Cwqxhv Vdakuo Edkx Stara Zagora Bulgaria
Micilwd Cabner Otidad Otd Burgas Bulgaria

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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