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Study of Tildrakizumab for Eye Problems in Patients with Lyell Syndrome

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What is this trial about?

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

This study looks at Lyell syndrome, a severe skin condition that can lead to long-lasting eye problems even after the initial illness has passed. People who have had Lyell syndrome may continue to experience eye issues such as dryness, irritation, and inflammation of the eye surface, which can affect their vision and daily comfort. The treatment being tested is Ilumetri, which contains the active substance tildrakizumab. This medicine is given as an injection under the skin and works by affecting the immune system to reduce inflammation. The study will use doses up to 200 milligrams per injection, with a total amount of up to 600 milligrams over a treatment period of three months.

The purpose of the study is to see if tildrakizumab can improve the eye problems that remain after Lyell syndrome. The main focus is on measuring how long the tear film stays stable on the eye surface before breaking up, which is an important sign of eye surface health. A longer time means better moisture and less irritation. The study will also look at how patients feel about their eye symptoms and how these problems affect their quality of life and ability to see clearly.

During the study, participants will receive the treatment and attend follow-up visits where doctors will check their eyes and measure changes in tear film stability. Safety will be monitored throughout the study, and participants will be asked about how well they tolerate the treatment and any changes in their symptoms. The study is expected to run from early 2026 until mid-2027.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment
On Day 0, an initial evaluation will be performed to measure the current condition of your eyes.
The tear film break-up time will be measured. This test shows how long the tear layer on your eye remains stable before breaking up. It is measured in seconds.
Your visual acuity will be assessed to determine how well you can see.
A complete ocular examination will be conducted to evaluate the surface of your eyes and any signs of inflammation.
You will be asked to complete questionnaires about your eye symptoms and how they affect your daily life and vision-related quality of life.
Step 2
Treatment with tildrakizumab
You will receive tildrakizumab, which is the active substance being tested in this study.
The medication will be administered as an injection under the skin (subcutaneous injection).
The dose is 200 mg per injection.
The medication comes in a pre-filled syringe ready for injection.
The specific schedule of injections, including how often and for how long you will receive the treatment, will be determined according to the study protocol.
Step 3
Follow-up visits
You will attend scheduled follow-up visits after starting treatment.
During these visits, the same measurements from the baseline assessment will be repeated.
The tear film break-up time will be measured again to see if there has been any change compared to Day 0.
Your eye condition will be examined to monitor any improvements or changes.
You will complete questionnaires about your eye symptoms and quality of life to assess how the treatment has affected you.
Your overall health and any side effects will be monitored for safety.
Information about your experience with the treatment and its tolerability will be collected using a specific questionnaire.

Who can join the trial?

8 criteria

You must be 18 years old or older
You must have eye problems that developed after Lyell syndrome, which is a severe skin reaction that can also affect the eyes
If you are a woman, you must not be pregnant and not be breastfeeding
You must have a history of SJS/TEN, which are medical names for severe skin reactions including Lyell syndrome, and you must still have ongoing eye symptoms or signs showing long-term inflammation of the eye surface, meaning irritation and swelling of the outer part of the eye
Your vision must be good enough to allow the doctors to perform the necessary eye tests and examinations
Your overall health condition must be stable enough to safely undergo eye examinations without risk
You must be able to understand and sign a consent form agreeing to participate in the study
You must be covered by social security or health insurance

Who cannot join the trial?

2 criteria

The study has not provided specific exclusion criteria, which are conditions or situations that would prevent a patient from joining this clinical trial
Please consult with the research team directly to learn about any specific health conditions, medications, or other factors that might prevent participation in this study

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Investigated drugs

Tildrakizumab is a medication that works by blocking certain proteins in the body that cause inflammation. In this study, it is being tested to see if it can help treat eye problems that occur as a result of Lyell syndrome, a serious skin condition.

Tildrakizumab

What is already known about the treatment

Tildrakizumab – Tildrakizumab is a medication given as an injection under the skin that is being studied for treating eye complications that occur after Lyell syndrome, a severe skin condition. This drug is a type of biological therapy that works by blocking a specific protein called interleukin-23, which plays a role in causing inflammation in the body. By blocking this protein, Tildrakizumab helps reduce inflammation and may improve the eye problems that can develop following Lyell syndrome. Currently, this medication is approved for treating certain skin conditions like psoriasis, and researchers are investigating whether it can also help patients with eye damage caused by Lyell syndrome.

Investigated diseases

Lyell Syndrome – Lyell syndrome, also known as toxic epidermal necrolysis, is a severe skin condition that causes widespread damage to the skin and mucous membranes. The disease begins suddenly, often with fever and flu-like symptoms, followed by painful red or purplish skin that rapidly blisters and peels off in large sheets. The condition affects not only the skin but also the eyes, mouth, and other mucous membranes throughout the body. Eye involvement can lead to serious complications including damage to the surface of the eye, problems with tear production, and scarring of the delicate tissues. As the disease progresses, patients may experience ongoing eye problems even after the acute phase has resolved, including dry eyes and difficulty maintaining a stable tear film. The eye-related aftereffects can persist long-term and significantly impact vision and daily comfort.