Not yet recruitingPHASE2INTERVENTIONAL

Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.

This research is looking into a new medication called Upadacitinib for two serious types of lichen planus: one that causes sores in the mouth and other moist areas (erosive mucosal lichen planus), and another that leads to hair loss on the scalp (lichen planopilaris). Lichen planus is an immune condition that can cause itching, pain, and visible damage, severely impacting daily life. Currently, there's no approved treatment in the UK or US. Upadacitinib is a drug that works by calming down parts of the immune system. This study will involve people aged 18 to 65, and some will receive the active medicine while others receive a dummy pill (placebo). The main goal is to find out if Upadacitinib is safe and effective in improving these conditions.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Aug 2028

Lichen Penis Planus

What is this study about?

Lichen planus is a common skin condition caused by your immune system mistakenly attacking healthy cells. It can affect different parts of the body, including your skin, nails, and hair. This study focuses on two more challenging forms: one that causes painful sores in moist body areas like the mouth (called erosive mucosal lichen planus) and another that leads to hair loss on the scalp (called lichen planopilaris).

These types of lichen planus can be very uncomfortable, painful, or distressing due to the changes they cause, and they can significantly affect how people live their daily lives. Unfortunately, current treatments often don't work well for everyone, and there isn't a specific medication for lichen planus approved for use in the UK or the US. This means doctors are always looking for better ways to help patients.

This study is testing a medicine called Upadacitinib. It works by blocking a specific pathway in the immune system that is thought to play a role in lichen planus. Early reports suggest that medicines like Upadacitinib might help, but more research is needed to be sure. The aim of this study is to find out if Upadacitinib is a safe and effective option for treating these severe forms of lichen planus, hoping to improve symptoms and quality of life for those affected.

Key takeaways

This study is testing a new drug for severe types of lichen planus.
It targets painful mouth sores or scalp hair loss caused by lichen planus.
Participants will get either the study drug or a dummy pill.
The drug aims to calm an overactive immune system.
It's for adults aged 18-65 whose current treatments aren't working.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. Doctors will need to confirm you have either an active form of erosive mucosal lichen planus (affecting moist areas of the body) or lichen planopilaris (causing hair loss on the scalp). Your condition should be considered moderate or severe by the study doctors, and previous treatments like strong steroid creams for your condition shouldn't have worked well enough.

There are also some reasons why you might not be able to join. For example, if your lichen planus is thought to be caused by a particular medication or if doctors suspect it's linked to another serious illness. You also can't join if your oral lichen planus is so severe you can't eat properly, or if you have certain types of severe scarring hair loss.

Other reasons for not joining include a history of recent drug or alcohol misuse, certain serious infections (like active tuberculosis or HIV), or frequent infections like cold sores. If you are a woman who could become pregnant, you would need to have negative pregnancy tests and agree to use effective birth control during the study.

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 between 18 and 65 years old?
Have you been diagnosed with either erosive mucosal lichen planus or lichen planopilaris?
Has your doctor rated your condition as moderate or severe?
Have strong steroid creams for your condition not worked well enough?
Do you have any active serious infections (like TB or HIV)? (If yes, you likely can't join)
Are you willing to use effective birth control if you can become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a screening visit to check if you're suitable. Once confirmed, you'll be randomly assigned to either receive the study medicine (Upadacitinib) or a dummy pill (placebo) – neither you nor your study doctor will know which one you are getting. You will take the assigned medication once a day.

You will have several clinic visits over a period of time, where the study team will monitor your health, check your symptoms, and perform tests. This will help them understand how your body is reacting to the treatment. There will also be a follow-up period after you stop taking the study medication to see how you are doing. The total duration of your participation in the study, including screening and follow-up, will be determined by the study protocol, but typically clinical trials like this last for several months.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of receiving a new treatment that could improve your lichen planus symptoms, especially if other treatments haven't worked well for you. However, there's no guarantee that the treatment will help, and you might receive a placebo. All medications, including Upadacitinib, can have side effects, and some people might experience them. The study team will closely monitor you for any potential side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

CHU de Nice
Verified postcode
Nice, France
APHP
Verified postcode
Paris, France
Centre privé de Dermatologie
Verified postcode
Reims, France
CHU de Rouen
Verified postcode
Rouen, France
CHU de Tours
Verified postcode
Tours, France

Common questions

What is Upadacitinib?

It's a new medicine being tested that aims to calm down an overactive part of your immune system, which is believed to cause lichen planus.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your doctor will know whether you are receiving the active drug or the placebo. This is to keep the study fair.

What types of lichen planus can join this study?

This study is for people with severe erosive mucosal lichen planus (affecting moist areas like the mouth) or lichen planopilaris (causing hair loss on the scalp).

What if I get pregnant during the study?

If you are able to become pregnant, you will need to use effective birth control throughout the study. If you were to become pregnant, your participation in the study medication phase would need to stop.

How to find out more

Thierry Passeron, PhD

passeron.t@chu-nice.fr +33492034924 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.