AuthorisedTherapeutic exploratory (Phase II)Interventional

Evaluation of Tildrakizumab in the Treatment of Ocular Sequelae in Lyell syndrome

This study is investigating a new medicine called Ilumetri (tildrakizumab) for people who have developed eye problems after Lyell syndrome. Lyell syndrome, also known as Toxic Epidermal Necrolysis, can sometimes lead to uncomfortable and lasting eye issues. This trial, a Phase II study, is designed to see how effective Ilumetri might be. Researchers will measure how much better the tears stay on the eye's surface, which is a key indicator of eye health. They will also collect information directly from patients about how their eye symptoms and vision affect their daily lives, to understand the real-world benefits of the treatment. The main goal is to explore if this medicine can help improve eye comfort and vision for these patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

TOXILYON

Enrolment target

Start

23 Jan 2026

Ocular Sequelae in Lyell syndrome

What is this study about?

This research study is about finding new ways to help people who have developed eye problems because of a serious skin condition called Lyell syndrome. Lyell syndrome, also known as Toxic Epidermal Necrolysis, is quite rare but very severe, causing skin to peel off in large sheets. Unfortunately, some people who recover from Lyell syndrome can be left with long-lasting and often uncomfortable eye problems. These can include dry eyes, irritation, and sometimes even vision difficulties.

The study is looking at a medicine called Ilumetri (which is also known as tildrakizumab). This medicine is given as an injection. Researchers want to understand if Ilumetri can help improve these eye problems. They will be checking how well the medicine works by measuring how long a thin layer of tears stays on the eye before it breaks up. This is an important way to tell if the eye's surface is healthier and more comfortable.

Crucially, the study also wants to hear directly from patients. Participants will be asked about their eye symptoms and how these symptoms affect their daily life and vision. This feedback is very important because it helps doctors understand if the medicine makes a real difference in how people feel and live, not just what can be measured in a clinic. This is a 'Phase II' study, which means it's an early step in testing a new medicine, focusing on whether it's safe and shows promise in helping patients.

Key takeaways

This study is for adults with eye problems due to Lyell syndrome.
It tests a new injectable medicine called Ilumetri (tildrakizumab).
Researchers will check tear health and listen to patient experiences.
It's a Phase II study, focusing on safety and early effectiveness.
Participation involves clinic visits, injections, and health checks.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.

The main requirement is that you must have experienced eye problems that are a result of having had Lyell syndrome. This study is specifically for those who have these particular eye issues.

There will be other specific health checks and criteria that a study doctor will need to review to make sure this study is right and safe for you. These checks might include looking at your general health, other current medications, and your full medical history.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Lyell syndrome in the past?
Do you currently have eye problems that developed after your Lyell syndrome?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, Ilumetri, which is an injection. You'll have several visits to the clinic, starting from a baseline visit (Day 0) before any treatment begins. During these visits, the study team will carry out various assessments. They will measure how long your tears stay on your eyes (tear film break-up time).

You will also be asked to complete questionnaires about your eye symptoms and how your vision affects your quality of life. These are called 'patient-reported outcomes' and are very important for understanding how you feel about the treatment. The study will also carefully monitor your health and any side effects to make sure the treatment is safe for you. The total duration of your participation will involve the treatment period and follow-up visits.

Potential risks and benefits

Participating in this study might offer a potential benefit of improving your eye problems related to Lyell syndrome more effectively than current treatments. However, like all medicines, Ilumetri may have side effects, and some risks are currently unknown as it's a new treatment being studied. Your health will be closely monitored throughout the study. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Lyell syndrome?

Lyell syndrome, also known as Toxic Epidermal Necrolysis, is a very rare but serious skin condition where the top layer of skin peels off over large parts of the body.

What are 'ocular sequelae'?

This simply means eye problems or difficulties that continue after a serious illness, in this case, after Lyell syndrome.

What is Ilumetri (tildrakizumab)?

Ilumetri is the name of the medicine being tested. It's a new type of treatment given by injection that researchers hope will help with the eye problems caused by Lyell syndrome.

Is this a new medicine?

Yes, this is a Phase II study, which means it's an earlier stage of testing a new medicine to see if it's safe and effective for this specific condition before it can be widely used.

Will I receive real medicine or a placebo?

The information provided only mentions Ilumetri as an intervention. You should discuss with the study team if there is a possibility of receiving a placebo (dummy treatment) in this specific trial.