Not recruitingRare disease

Study on the Safety and Effectiveness of LASN01 for Patients with 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, a condition often associated with Graves' disease that can cause swelling and discomfort around the eyes. The study will evaluate a new treatment called LASN01, which is administered as a solution for injection. The purpose of the study is to assess the safety and effectiveness of two different dose levels of LASN01 in patients with this condition. Participants in the study will receive either the treatment or a placebo, which is a substance with no active medication.

Throughout the study, participants will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will last for a period of up to 24 weeks, during which time participants will be closely monitored by healthcare professionals. The study aims to observe changes in the symptoms of Thyroid Eye Disease, such as eye bulging and other related eye issues, to determine if LASN01 is effective in reducing these symptoms.

Participants will undergo regular check-ups, including physical examinations and laboratory tests, to ensure their safety and to monitor any potential side effects of the treatment. The study will also involve measuring the concentration of LASN01 in the blood at various times to understand how the body processes the medication. This research is important for developing new treatments that could improve the quality of life for people with Thyroid Eye Disease.

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, eligibility is confirmed based on specific criteria such as age, diagnosis of Graves' disease with active thyroid eye disease (TED), and other health conditions.
Participants must not have received certain treatments for TED, except for specific medications like mycophenolate and steroids.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating eye conditions using tools like an exophthalmometer to measure eye protrusion.
Other health evaluations include laboratory tests, vital signs, and physical examinations.
Step 3
Treatment administration
Participants receive the study medication, LASN01, through an intravenous infusion. The dosage and frequency are determined by the study protocol.
The treatment aims to assess the safety and effectiveness of two different dose levels of LASN01.
Step 4
Ongoing monitoring
Throughout the study, participants undergo regular monitoring to track changes in eye conditions and overall health.
This includes measuring changes in proptosis, clinical laboratory evaluations, and monitoring for any adverse events.
Step 5
Final assessment
At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment.
This includes a comprehensive review of eye conditions, health status, and any side effects experienced during the study.

Who can join the trial?

6 criteria

Must be a male or female patient who is at least 18 years old at the time of screening.
Must have a clinical diagnosis of **Graves' disease** with active **Thyroid Eye Disease (TED)**. Graves' disease is a condition that affects the thyroid gland, and TED is an eye condition related to it.
Must have moderate-to-severe active TED.
Must have had TED symptoms for less than 15 months.
Must not have had previous medical treatment for TED, except for local supportive measures, mycophenolate, oral or injectable steroids, or immunomodulating therapies. Must not have had surgical treatment in the study eye or orbital radiation.
Female patients must be nonpregnant, nonlactating, surgically sterile for at least 6 months, or agree to use a highly effective method of contraception. Male patients must be surgically sterile or agree to use a highly effective method of contraception.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could 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 who have a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or attend study visits.
Patients who have used certain medications that might affect the study results.
Patients who have a history of drug or alcohol abuse.
Patients who have an uncontrolled infection.
Patients who have a history of cancer, except for certain types that have been treated successfully.

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Verified sites

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

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Clinica De Oftalmologia De Cordoba S.L.
Cordoba, Spain
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Universitaetsklinikum Essen AöR
Essen, Germany
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Universitaetsklinikum Tuebingen AöR
Tuebingen, Germany

Trial locations

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Investigated drugs

LASN01 is an investigational medication being studied for its potential to treat thyroid eye disease. In this clinical trial, the medication is given to patients through an intravenous (IV) infusion. The main goal of the study is to assess how safe and effective LASN01 is for people with thyroid eye disease.

What is already known about the treatment

LASN01 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential use in treating Thyroid Eye Disease, a condition that affects the eyes. The main goal of the ongoing research is to assess its safety and effectiveness. LASN01 works at the molecular level by targeting specific pathways involved in the inflammation and tissue changes associated with the disease. It is classified pharmacologically as an investigational drug, as it is still under study and not yet approved for general medical use.

Investigated diseases

Thyroid Eye Disease – This is an autoimmune condition where the immune system mistakenly attacks the tissues around the eyes, leading to inflammation and swelling. It is often associated with Graves' disease, a disorder that affects the thyroid gland. The disease can cause symptoms such as bulging eyes, redness, and discomfort. As it progresses, patients may experience double vision, eyelid retraction, and difficulty closing the eyes completely. The severity of symptoms can vary, and the condition may go through phases of worsening and improvement. Over time, the inflammation can lead to changes in the appearance and function of the eyes.