Study on the Effectiveness and Safety of IMVT-1402 for Adults with Graves’ Disease

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What is this study about?

This clinical trial is focused on studying Graves’ Disease, an autoimmune condition that affects the thyroid gland, causing it to produce too much thyroid hormone. The study will evaluate a new treatment called IMVT-1402, which is administered as a solution for injection. The purpose of the study is to assess the effectiveness and safety of IMVT-1402 compared to a placebo in treating adults with Graves’ Disease.

Participants in the study will receive either the new treatment, IMVT-1402, or a placebo, which looks the same but contains no active ingredients. The study will last for a period of up to 52 weeks, during which participants will be monitored to see how well the treatment works and to check for any side effects. The main goal is to see if participants can maintain normal thyroid function without the need for additional medication.

Throughout the study, participants will have regular check-ups to measure thyroid hormone levels and ensure their well-being. The study aims to provide valuable information on whether IMVT-1402 can be a safe and effective treatment option for people with Graves’ Disease.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the investigational medication IMVT-1402 or a placebo. A placebo looks like the investigational medication but does not contain any active ingredients.

2 medication administration

The medication, whether IMVT-1402 or placebo, will be administered as a solution for injection under the skin, known as subcutaneous use.

3 treatment duration

The treatment will continue for a period of 26 weeks. During this time, the effects of the medication on your condition will be closely monitored.

4 monitoring and assessments

Throughout the study, regular assessments will be conducted to evaluate the effectiveness and safety of the treatment. These assessments will include measuring levels of certain hormones in your blood, such as T3, FT4, and TSH.

5 end of treatment evaluation

At the end of the 26-week treatment period, an evaluation will be conducted to determine if you are euthyroid, meaning your thyroid hormone levels are within the normal range, and if you can discontinue the use of antithyroid drugs (ATD).

6 follow-up period

After the treatment period, there will be a follow-up phase to monitor your condition for an additional period, which may extend up to 52 weeks or longer, depending on your response to the treatment.

Who Can Join the Study?

Must be between 18 and 75 years old at the time of signing the consent form.
Must have a prior diagnosis of Grave’s Disease.
Must have a TSH value (a hormone level) of less than 0.1 mIU/L as measured by the local laboratory at the screening visit.
Must meet one of the following conditions regarding ATD (anti-thyroid drugs) use:
- Have been on ATD for at least 3 months before the screening visit and:
  - Currently taking ATD with a dose of at least 20 mg/day methimazole or equivalent (like 30 mg/day carbimazole or 200 mg/day propylthiouracil) for the 4 weeks before the screening visit.
  - Expected to continue on a stable dose of ATD for the 4 weeks before randomization.
- Have been on ATD for at least 6 months before the screening visit and:
  - Have been treated with at least 15 mg/day methimazole or equivalent (like 20 mg/day carbimazole or 150 mg/day propylthiouracil) at any point during treatment history.
  - Currently taking ATD with a dose of at least 10 mg/day methimazole or equivalent (like 15 mg/day carbimazole or 100 mg/day propylthiouracil) for the 4 weeks before the screening visit.
  - Expected to continue on a stable dose of ATD for the 4 weeks before randomization.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients who are unable to comply with the study procedures.
Patients with known allergies to the study medication or its ingredients.
Patients with uncontrolled high blood pressure.
Patients with severe liver or kidney disease.
Patients with a history of heart disease.
Patients who have had a major surgery within the last 3 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Trial Pharma Kft.	Gyula	Hungary
Hospital Universitario De Navarra	Pamplona	Spain
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
ARNAS Garibaldi Di Catania	Catania	Italy
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Reumed Sp. z o.o.	Lublin	Poland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Eb Group Sp. z o.o.	Warsaw	Poland
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
University Of Debrecen	Debrecen	Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Semmelweis University	Budapest	Hungary
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.	Poznan	Poland
University Of Pecs	Pecs	Hungary
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
University Of Szeged	Szeged	Hungary
Muifrazil Mejzdqm guxqg	Munich	Germany
Hubovhek Uwqkcrmsjsyca Do Lr Pktfpsgp	Madrid	Spain
Isldtr	Bonheiden	Belgium
Cercciv Mjcwdzrt Hrlv Cvhcbq	Lublin	Poland
Alvhhuz Ozwwyklwhaz Ufxapjhbybfph Sdjepj	Siena	Italy
Njwkqgsn Irrwkyab Ordpdwmck Ipx Mhwkt Sgvluqcbzzetteanlxvtmbqmuxxr Idcrllkn Blwwlres	Cracow	Poland
Kyyvcczh dgk Uiddmivmlcqd Mxwwmmzn Aux	Munich	Germany
Uhalnxgyzgkogroorwhtb Whygygbnq Aeu	Wuerzburg	Germany
Acvowsh Uvkvh Spkkdsdfx Likgtt Dm Blkepsc	Bologna	Italy
Hfvwlnqo Ujujwsjxzokbo Hhikpypb Tnbga y Ptxhdk Ibihgluq Ccoopv dxhtcvyomqzmvbvmg (dqaw	Badalona	Spain
Hsonxuqh Vzbh dsgdunmo	Barcelona	Spain
Ibbqv Ongqyihx Amufzjoith Soj Lmmz	Milan	Italy

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.06.2025
Germany	Recruiting	01.06.2025
Hungary	Recruiting	01.06.2025
Italy	Recruiting	01.06.2025
Poland	Recruiting	01.06.2025
Spain	Recruiting	01.06.2025

Trial locations

Investigated drugs:

IMEROPRUBART

IMVT-1402 is a medication being studied for its potential to help treat Graves’ Disease, a condition where the thyroid gland is overactive. This medication is being tested to see if it can help control the levels of certain hormones in the body, such as T3, FT3, FT4, and TSH, which are important for regulating metabolism and energy. The goal is to see if IMVT-1402 can help bring these hormone levels back to normal, which may help reduce the symptoms of Graves’ Disease and improve the overall health of patients. The study is also looking at how safe and well-tolerated this medication is for people who take it.

Investigated diseases:

Graves' disease

Graves’ Disease – Graves’ Disease is an autoimmune disorder that leads to the overactivity of the thyroid gland, known as hyperthyroidism. The immune system mistakenly attacks the thyroid, causing it to produce excessive amounts of thyroid hormones. This results in symptoms such as rapid heartbeat, weight loss, increased appetite, and nervousness. As the disease progresses, individuals may experience swelling of the neck due to an enlarged thyroid gland, known as a goiter. Eye problems, such as bulging eyes or irritation, can also occur. The progression of the disease can vary, with periods of worsening symptoms and times of improvement.

Trial ID:

2024-516020-33-00

Protocol code:

IMVT-1402-2502

NCT ID:

NCT06727604

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of IMVT-1402 for Adults with Graves’ Disease

What is this study about?

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