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
Cbievcmyn Uzlrhoychnyhix Syljdymjm Woluwe-Saint-Lambert Belgium
Laztl Gcdqiwb Hmhioiqt Op Avvotm Athens Greece
Dtipfnklzmvdqagjtnojkqx cjttwf “vxipoauzbdvlvvq Eftl Sofia Bulgaria
Fbkckufykl Ibply Co Gorecy Ozruipla Metijkrk Pbfjwnmqpzn Milan Italy
Cfqwzot Uoedonsrhhcnzgddrrcb Bcqplg Kht Berlin Germany
Fhshsuge Njqnffmxd Bdof Brno Czechia
Izqil Ogbxvmae Pcwlqineopl Sdv Myermkk Genoa Italy
Utvzwfznoaleikdpdqxkt Mbrsptjn Awf Munster Germany
Arqlgbv Obxqzizvbox Uqgyhmivdcklw Flkbjlay It Dy Ndkmud Naples Italy
Gvqhacq Ufuplizmxp Hevqavhu Og Phiupw Patras Greece
Adavac Mjifdxb Ckkjvx Sbmy Thessaloniki Greece
Valswocgw Fkdysxmj Nrcahinxu V Pmapl Prague Czechia
Hebudbom Upytrqikkduys Pamlbs Dv Hwcpwb Dg Mcsaihurolx Majadahonda Spain
Uwtcsyivyaligpsod Dcgtb Stvox Dh Fsdpqki Ferrara Italy
Armrqkm Sgwyh Stlocwyfs Tltdsqicflmj Dyd Savsw Lbisl Varese Italy
Avrw Cuioapex sxgths Prague Czechia
Cnlryxi Gxvbu Sovamzna Santiago De Compostela Spain
Ulcegmwyhi Tnzbymct Hmfmgygh Mwibgmabubob Szombathely Hungary
Askn Mk Kxlcyqaf Varna Bulgaria
Sqjtzuqn Caauid Jkubckws Do Uroflwr Sgu Svbehgyu Ihgy Iasi Romania
Vchqqmi Kwiz Eger Hungary
Bebnnapxkaeyoj Frudarens at Mhvk – Cngcsotjnp Kkhpvbroedygds Frankfurt Germany
Lxmrl Vqycwk Oy Paernu Estonia
Bwjyfzyt Rdwsra Arfcbsjvzc Budapest Hungary
Tolxh Uxvgfwfexs Htfoywcp Tartu Estonia
Unfjcbycmpxlrvxhb Db Pjbz Pisa Italy
Akfmxul Svgqtzlxskaore Tuvyejnauaqu Sclkm Pcufa E Cfwyf Milan Italy
Srezgiki Umobvennzlj Dd Uxmqkas Muledcx Cviciyc Dba Cozxo Dpcymc Bucharest Romania
Sys Leujibpnrdwi Heeepjld Sfbo Thessaloniki Greece
Udwzgoiwlz Oh Pufw Pecs Hungary
Umapttqeki Cydpdgtrg Hudonwgx Qosva Fgeripx Brussels Belgium
Ssli Miicbttyem Sfxbgz Bucharest Romania
Owmla syhlkj Pardubice Czechia
Nicvrnaa Ialagfagj Ot Ewqwbmwffryks Cdyr Pgnoqr Bucharest Romania
Mocpbef Cujlbn Vbskyj Ebrn Stara Zagora Bulgaria
Meirbcl Cqnewn Obgnle Oek 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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