Not recruitingRare disease

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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Thyroid Eye Disease (TED), a condition where the muscles and tissues around the eyes become inflamed, leading to symptoms like bulging eyes, discomfort, and vision problems. The study will evaluate the effects of a medication called linsitinib, which is taken as a film-coated tablet. Linsitinib is being tested to see if it can help reduce the symptoms of TED, particularly the bulging of the eyes, also known as proptosis.

The purpose of the study is to assess the effectiveness and safety of linsitinib in individuals with moderate to severe TED. Participants in the study will receive either linsitinib or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for 24 weeks, during which participants will take the medication and have regular check-ups to monitor their condition and any changes in their symptoms.

Throughout the study, researchers will focus on measuring the change in eye bulging and other symptoms to determine how well linsitinib works. The goal is to find out if linsitinib can provide relief for people with TED by reducing the severity of their symptoms without causing significant side effects. This study is an extension of previous research and aims to provide more information on the potential benefits of linsitinib for those affected by this eye condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be assessed to ensure they meet the necessary criteria. This includes having completed a previous study and not having received any treatment for thyroid eye disease since the last study's 24-week mark.
Participants must have their thyroid levels under control or only slightly out of range. If necessary, adjustments will be made to maintain stable thyroid levels throughout the study.
Step 2
Baseline assessment
A baseline assessment will be conducted to measure the current state of the eye condition. This includes measuring the degree of eye protrusion, known as proptosis.
Participants must not require immediate eye surgery or other interventions at this time.
Step 3
Medication administration
Participants will receive either the active medication, linsitinib, or a placebo. The medication is in the form of a film-coated tablet taken orally.
The dosage is 75 mg, and the medication is taken as directed by the study team. The duration of administration is up to 24 weeks.
Step 4
Regular follow-up visits
Participants will attend regular follow-up visits to monitor their condition and any changes in eye protrusion.
These visits will help assess the effectiveness and safety of the medication.
Step 5
Final assessment
At the end of the 24-week period, a final assessment will be conducted to evaluate the response to the treatment.
The primary goal is to determine if there has been a significant reduction in eye protrusion without worsening in the other eye.

Who can join the trial?

7 criteria

The study is for people with Thyroid Eye Disease.
You must have completed a previous 24-week study called VGN-TED-301.
You should either not have shown improvement in eye bulging (less than 2 mm reduction) by the end of the previous study or have shown improvement but then worsened during the follow-up period.
You must not have received any treatment for Thyroid Eye Disease since the end of the previous study.
Your thyroid levels should be stable, meaning you are euthyroid (normal thyroid function) or have only mild thyroid hormone imbalances. If your thyroid levels are slightly off, efforts should be made to correct them.
You should not need immediate eye surgery, radiation treatment to the eye area, or other eye-related procedures at the start of the study and should not plan to have any during the study.
Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

Patients who have not completed Week 24 of the lead-in study VGN-TED-301 cannot participate.
Patients who have a medical condition other than Thyroid Eye Disease that could interfere with the study results cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they may need special protection or care, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
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Hospital Universitario De La Princesa
Madrid, Spain

Trial locations

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Investigated drugs

Linsitinib is a medication being studied for its potential to help people with Thyroid Eye Disease, a condition that can cause the eyes to bulge and lead to discomfort and vision problems. In this clinical trial, researchers are looking at how well Linsitinib can reduce the bulging of the eyes, which is measured by a decrease in the distance the eyes protrude. The goal is to see if Linsitinib can help improve the condition without causing the other eye to worsen. This study is an extension of a previous trial, meaning it continues to explore the effects of Linsitinib over a longer period to better understand its benefits and safety for patients with moderate to severe Thyroid Eye Disease.

Linsitinib

What is already known about the treatment

Linsitinib – Linsitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating Thyroid Eye Disease, a condition that affects the eyes. It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for Linsitinib is to reduce eye protrusion in patients with moderate to severe Thyroid Eye Disease. At the molecular level, Linsitinib works by inhibiting certain proteins that are involved in the growth and survival of cells, which may help reduce inflammation and tissue expansion in the eye area. It is classified as a tyrosine kinase inhibitor, a type of drug that blocks specific enzymes involved in cell signaling.

Investigated diseases

Thyroid Eye Disease – Thyroid Eye Disease is an autoimmune condition that affects the muscles and other tissues around the eyes. It is often associated with an overactive thyroid gland, known as hyperthyroidism. The disease causes inflammation and swelling, leading to symptoms such as bulging eyes, redness, and discomfort. As the condition progresses, individuals may experience double vision and difficulty moving the eyes. The disease can also cause the eyelids to retract, giving the eyes a wide-open appearance. Over time, the inflammation may decrease, but some changes, like bulging, can persist.