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Study on the Safety and Efficacy of 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 a condition known as Thyroid Eye Disease (TED), which can cause eye problems in people with certain thyroid conditions like Graves' Disease or autoimmune Hashimoto’s thyroiditis. The study will test a medication called Linsitinib, which is taken as a film-coated tablet, to see if it can help improve symptoms in patients with active, moderate to severe TED. Some participants will receive Linsitinib, while others will receive a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to evaluate the safety and effectiveness of Linsitinib in treating TED. Participants will be randomly assigned to receive either Linsitinib or a placebo. The study will last for 24 weeks, during which time the effects of the medication on eye symptoms will be closely monitored. The main focus will be on changes in eye bulging, known as proptosis, and other symptoms related to TED.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The study aims to determine if Linsitinib can reduce the severity of TED symptoms and improve the quality of life for those affected by this condition. The results will help understand the potential benefits of Linsitinib for people with TED.

The research process

The trial runs in 6 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, the patient will be assessed to confirm a clinical diagnosis of Graves' Disease or autoimmune Hashimoto's thyroiditis associated with active, moderate to severe thyroid eye disease (TED).
The patient must have a Clinical Activity Score (CAS) of 4 or more for the most affected eye at both the screening and baseline visits.
Step 2
Initial assessment
The patient will undergo an initial assessment to ensure they are euthyroid, meaning their thyroid hormone levels are within normal limits, or have mild hypo- or hyperthyroidism.
This assessment will include measuring free thyroxine (FT4) and free triiodothyronine (FT3) levels.
Step 3
Randomization and treatment
The patient will be randomly assigned to receive either linsitinib or a placebo. Linsitinib is administered in the form of a film-coated tablet taken orally.
The dosage and frequency of administration will be determined by the study protocol, and the patient will be required to follow this regimen for the duration of the study.
Step 4
Ongoing assessments
Throughout the study, the patient will have regular assessments to monitor the effect of the treatment on their condition.
These assessments will include measuring changes in proptosis (eye bulging) and evaluating the Clinical Activity Scale (CAS) score.
Step 5
Primary evaluation at week 24
At week 24, the primary evaluation will occur to determine the proptosis responder rate, which is the main objective of the study.
Secondary evaluations will also be conducted to assess changes in proptosis measurement, CAS scores, and the overall quality of life as measured by the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire.
Step 6
Completion of the study
The study is estimated to conclude by November 21, 2025.
Upon completion, the patient will undergo a final assessment to evaluate the overall impact of the treatment on their condition.

Who can join the trial?

7 criteria

Must have a clinical diagnosis of **Graves' Disease** or **autoimmune Hashimoto's thyroiditis**. These are conditions related to the thyroid gland.
Must have **active moderate to severe TED** (Thyroid Eye Disease) with a **CAS** (Clinical Activity Score) of 4 or more for the most affected eye. CAS is a way to measure how active the eye disease is.
TED should not be sight-threatening but should have a noticeable impact on daily life. The diagnosis of TED should have been made within 12 months before the screening visit.
TED is usually associated with one or more of the following: **lid retraction** of 2 mm or more (eyelid pulled back), moderate or severe soft tissue involvement, **exophthalmos** (bulging of the eye) of 3 mm or more above normal for race and gender, and/or **diplopia** (double vision) that is not constant or is constant.
Participants must be **euthyroid**, meaning their thyroid function is normal, or have mild **hypothyroidism** (low thyroid function) or **hyperthyroidism** (high thyroid function). This is defined by specific levels of thyroid hormones (FT4 and FT3) being less than 50% above or below normal limits at screening.
Both male and female participants are eligible.
Participants should not be from a vulnerable population.

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Verified sites

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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 treat moderate to severe Thyroid Eye Disease (TED). It is being evaluated for its safety, how it is processed in the body, and its effectiveness in reducing the symptoms of TED, particularly the bulging of the eyes, known as proptosis. The trial aims to determine how well patients respond to this treatment over a 24-week period.

Linsitinib

What is already known about the treatment

Linsitinib – Linsitinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating moderate to severe Thyroid Eye Disease (TED). The medication works by inhibiting certain enzymes that are involved in the signaling pathways, which can reduce inflammation and tissue expansion associated with TED. Linsitinib is classified as a tyrosine kinase inhibitor, a type of drug that blocks specific enzymes involved in the growth and spread of cells.

Investigated diseases

Thyroid Eye Disease – This condition, also known as Graves' Ophthalmopathy, is an autoimmune disorder 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 their eyes. The severity of symptoms can vary, and in some cases, the disease may stabilize or improve over time.