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Endocrine ophthalmopathy – Trials in Disease

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Ongoing Clinical Trials for Endocrine Ophthalmopathy

There are currently 19 clinical trials investigating new treatments for endocrine ophthalmopathy. These studies are testing various medications including monoclonal antibodies, immunosuppressants, and receptor inhibitors. Trials are taking place across multiple European countries, offering opportunities for patients with active or chronic forms of this eye condition. (Also known as: Thyroid Eye Disease, Graves’ Ophthalmopathy)

Clinical trial locations

Study Comparing Sirolimus and Methylprednisolone for Patients with Active Thyroid Eye Disease

This trial is comparing two different treatment approaches for active thyroid eye disease. Participants must have a confirmed diagnosis of Graves’ disease with moderate to severe active symptoms, including a Clinical Activity Score of 4 or more. The disease must have started within the last six months, and thyroid hormone levels should be normal or only slightly abnormal. Participants must be between 18 and 80 years old and agree to use reliable birth control methods during the study.

The trial excludes patients who do not have thyroid eye disease, are outside the specified age range, are unwilling to follow study procedures, have serious health conditions that could interfere, are pregnant or breastfeeding, or are taking certain medications that might affect the study. Those with recent eye surgery or allergies to the study medications are also excluded.

The study is testing Sirolimus, taken orally, against corticosteroids (Methylprednisolone) given as injections. The main goal is to determine whether Sirolimus is more effective and has fewer side effects than the conventional corticosteroid treatment. Participants will receive treatment for 12 months, during which researchers will monitor changes in eye symptoms such as bulging, lid retraction, and overall quality of life.

Study of Efgartigimod for Adults with Thyroid Eye Disease

This study is evaluating Efgartigimod, a medication administered through subcutaneous injections using a pre-filled syringe. Participants must be at least 18 years old with a diagnosis of active, moderate-to-severe thyroid eye disease associated with autoimmune thyroid conditions like Graves’ disease or Hashimoto’s thyroiditis. The onset of symptoms must have occurred within 12 months before screening, and participants should have normal thyroid function or mild thyroid issues that are controlled.

Exclusions include patients with other serious health conditions, those currently in another clinical trial, those with recent or planned surgery, pregnant or breastfeeding women, and those with certain uncontrolled medical conditions or recent treatments for the disease.

The trial compares Efgartigimod with a placebo to assess its effectiveness in reducing eye bulging (proptosis) over a 24-week period. The study will monitor changes in eye symptoms and overall quality of life, aiming to determine whether Efgartigimod can be a beneficial treatment option for this condition.

Study of Efgartigimod PH20 SC for Adults with Thyroid Eye Disease

This trial is testing Efgartigimod PH20 SC, which is also administered subcutaneously via a prefilled syringe. The inclusion criteria are similar to the previous Efgartigimod study: participants must be at least 18 years old with active, moderate-to-severe thyroid eye disease, symptoms starting within 12 months, and stable thyroid function. Birth control use is required for those of childbearing potential.

Exclusion criteria include having a different eye condition unrelated to thyroid eye disease, being outside the specified age range, inability to follow study procedures, current participation in another trial, recent or planned surgery, pregnancy or breastfeeding, and history of allergic reactions to the study medication.

The study evaluates the medication’s effectiveness in reducing proptosis and improving quality of life over a 24-week treatment period. The research aims to provide data on whether this formulation of Efgartigimod can effectively manage symptoms and improve the lives of people with thyroid eye disease.

Study on Batoclimab for Patients with Thyroid Eye Disease

This extension study focuses on Batoclimab, administered through subcutaneous injections. It is designed for participants who have previously completed another study involving Batoclimab. Eligibility requires completion of the Week 24 visit from the previous study and no immediate need for surgery or other treatments during the study period. Participants must not have permanently stopped taking the medication in the earlier study.

Patients with a different eye condition, those outside the specified age range, or those not part of the designated clinical trial groups are excluded. The study aims to understand how long the positive effects of Batoclimab last after stopping treatment and to assess the proportion of participants who continue to respond. The research monitors changes in eye protrusion and other symptoms to evaluate the long-term benefits and safety of the medication.

Study on Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

This trial is evaluating Linsitinib, taken as a film-coated tablet, in participants with moderate to severe active thyroid eye disease. Participants must have completed a previous 24-week study and either shown less than 2 mm reduction in eye bulging by the end of that study or experienced worsening during follow-up. They must not have received any treatment for the condition since the previous study ended, and their thyroid levels should be stable. Participants should not need immediate eye surgery or radiation treatment.

Exclusions include those who did not complete the previous study, have medical conditions that could interfere with results, are outside the specified age range, or are part of vulnerable populations. The study lasts 24 weeks and aims to determine if Linsitinib can reduce eye bulging without causing worsening in the other eye, providing valuable information on its potential as a treatment option for this condition.

Study on the Effects of TOUR006 for Adults with Thyroid Eye Disease

This trial tests TOUR006, a human IgG2 monoclonal antibody against IL-6, administered through subcutaneous injection. Participants must have a clinical diagnosis of Graves’ disease with moderate to severe active thyroid eye disease, with symptoms starting within approximately 15 months. Eye bulging must be 3 mm or more above normal, with a Clinical Activity Score of 4 or more. The presence of thyroid-stimulating immunoglobulin above specified levels is required.

Patients with conditions other than thyroid eye disease, those outside the age range of 18-75, those not in specified clinical trial groups, and those from certain vulnerable populations are excluded. The study evaluates whether TOUR006 can reduce eye bulging by at least 2 mm without worsening the other eye at Week 20. Secondary assessments track changes in disease activity, double vision, and quality of life throughout the study period.

Study on Treating Graves’ Eye Disease with Diclofenac or Simvastatin for Patients with Mild to Moderate Symptoms

This trial compares Diclofenac, a non-steroidal anti-inflammatory drug, and Simvastatin, a cholesterol-lowering medication, for mild to moderate Graves’ ophthalmopathy. Participants must be between 18 and 70 years old with mild to moderate disease, eye bulging up to 24 mm, and disease duration of less than 18 months. They must have Graves’ disease with normal thyroid function achieved through one of several treatment methods.

Exclusions include other serious eye diseases, recent eye surgery, current use of other treatments, pregnancy or breastfeeding, severe allergies to study medications, uncontrolled high blood pressure, severe liver or kidney disease, recent heart attack or stroke, and participation in another trial. The six-month study aims to determine if these medications can help manage disease activity and prevent progression to more severe forms while improving quality of life.

Study on the Effects of VRDN-003 for Patients with Active Thyroid Eye Disease

This study evaluates VRDN-003, an IGF-1R inhibitor given through subcutaneous injections either every four weeks or every eight weeks. Participants must be adults aged 18-75 with a clinical diagnosis of thyroid eye disease and a Clinical Activity Score of 3 or higher. They must have moderate to severe active disease with noticeable eye bulging and at least one other symptom. Eye-related symptoms must have started within 15 months before the first study visit, and participants must agree to use effective birth control.

Exclusions include not having the disease, being outside the age range, unwillingness to receive injections or a placebo, not being part of specified trial groups, and being from certain vulnerable populations. The 24-week study focuses on whether VRDN-003 can reduce eye bulging by at least 2 mm and improve the Clinical Activity Score without worsening disease severity, while also monitoring for side effects and body responses to the treatment.

Study of Batoclimab for Treating Patients with Active Thyroid Eye Disease

This trial evaluates Batoclimab, given as subcutaneous injections once weekly for 24 weeks. The first 12 weeks involve a dose of 680 mg, followed by 12 weeks at 340 mg. Participants must be at least 18 years old with active, moderate to severe thyroid eye disease, including a Clinical Activity Score of 4 or more and eye bulging of 18 mm or more. The disease must have started within 12 months before screening, with documented detectable anti-TSHR antibodies. Participants should not need immediate surgery and should have stable thyroid function.

Exclusions include different eye conditions, being outside the age range, inability to follow procedures, other serious health conditions, pregnancy or breastfeeding, recent participation in another trial, recent or planned surgery, substance abuse history, and allergies to the medication. The study compares Batoclimab with placebo to assess effectiveness in reducing eye bulging and improving other symptoms by the end of the 24-week period.

Study of VRDN-001 compared to placebo to evaluate safety and effectiveness in adults with chronic thyroid eye disease

This study tests VRDN-001, a humanized monoclonal antibody targeting the IGF-1 receptor, given through five intravenous infusions. Participants must be 18-75 years old with thyroid eye disease of any severity, moderate to severe chronic disease with eye bulging of at least 3 mm and more than 17 mm total. Symptoms must have started more than 15 months before screening. Birth control use is required, with negative pregnancy tests for females.

Exclusions include age under 18 or over 65, pregnancy or breastfeeding, previous orbital radiotherapy, active eye infection or severe inflammation, recent orbital decompression surgery, uncontrolled thyroid function, severe heart/liver/kidney disease, recent cancer, current smoking, recent use of other investigational drugs, substance abuse history, severe psychiatric conditions, allergies to study medication, inability to provide consent, and participation in another trial. The 12-week study evaluates safety, tolerability, and effectiveness in reducing symptoms.

Summary

The 19 ongoing clinical trials for endocrine ophthalmopathy demonstrate significant international research effort, with the majority of trials concentrated in Western and Central European countries. Germany, Spain, and Poland are particularly active locations, hosting ten or more trials each. France, Italy, Hungary, and the Netherlands also feature prominently as trial sites.

Several investigational medications appear in multiple trials, indicating focused research efforts. VRDN-001 and its related formulation VRDN-003 are being tested in six trials across various European countries. Batoclimab appears in four separate studies, including extension trials. Efgartigimod, in two formulations, is being evaluated in three trials. These patterns suggest that researchers are exploring these medications at different stages and in various patient populations.

The trials encompass different disease stages, from active moderate-to-severe disease to chronic forms, offering options for patients at various points in their disease journey. Treatment approaches vary widely, including monoclonal antibodies, immunosuppressants, receptor inhibitors, and repurposed medications like Diclofenac and Simvastatin. Most trials focus on reducing eye bulging (proptosis) as a primary outcome, with additional attention to quality of life measures and disease activity scores.

The geographic diversity of trial locations provides opportunities for patients across Europe to access experimental treatments. However, patients should note that trial participation requires meeting specific eligibility criteria and involves regular monitoring visits. Those interested in participating should discuss options with their healthcare providers to determine which trials, if any, might be appropriate for their specific situation.

Ongoing Clinical Trials on Endocrine ophthalmopathy

  • A study to test if atorvastatin can prevent eye disease in patients newly diagnosed with Graves’ disease

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Effects of VRDN-003 for Patients with Active Thyroid Eye Disease

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary The Netherlands Poland Spain

  • Study of VRDN-001 compared to placebo to evaluate safety and effectiveness in adults with chronic thyroid eye disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Hungary Italy Poland Spain

  • Study on the Safety and Tolerability of VRDN-003 for Patients with Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Poland Spain

  • Study on the Effectiveness and Safety of VRDN-003 for Patients with Chronic Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary The Netherlands Poland Spain

  • Study on Batoclimab for Treating Patients with Active Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Poland

  • Study of Efgartigimod PH20 SC for Adults with Thyroid Eye Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria France Germany Italy Latvia +4

  • Study of Efgartigimod for Adults with Thyroid Eye Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Estonia Germany Greece +4

  • Study of VRDN-001 for Patients with Thyroid Eye Disease Who Did Not Respond to Previous Treatment

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Italy The Netherlands +2

  • Study on the Safety and Efficacy of Linsitinib for Patients with Active, Moderate to Severe Thyroid Eye Disease

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

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