AuthorisedTherapeutic exploratory (Phase II)Interventional

Upadacitinib in adult patients with erosive mucosal Lichen Planus and Lichen Planopilaris: a prospective multicenter randomized placebo-controlled study. (Upa30-LP)

This research study is investigating a new treatment, upadacitinib (also known as RINVOQ), for adults who have erosive mucosal lichen planus or lichen planopilaris. These are conditions that can cause rashes and other symptoms. The study will compare upadacitinib with a placebo, which is a pill that looks the same but contains no active medicine. This helps researchers understand if the new medication is truly effective. The main goal is to see if participants' lichen improves significantly after 16 weeks of treatment. Researchers will also be looking at overall well-being, quality of life, and any side effects to make sure the treatment is safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

09 Mar 2026

Lichen

What is this study about?

This clinical trial, called Upa30-LP, is focused on finding better ways to treat two types of lichen: erosive mucosal lichen planus and lichen planopilaris. Lichen can cause uncomfortable skin rashes, and sometimes affects the lining of the mouth, throat, or other areas (mucosal), or even the scalp (planopilaris) leading to hair loss.

The study is testing a medication called upadacitinib, which is also known by its brand name, RINVOQ. This medication is given as a 30 mg tablet that releases slowly in your body. It's being compared to a 'placebo,' which is a pill that looks identical but doesn't contain the active drug. This comparison is very important for scientists to understand if any improvements seen are truly due to the medication or other factors. This particular trial is in "Phase II," which means it's an early-stage study to explore if the treatment is effective and safe.

The main aim is to see if the lichen improves significantly for participants after 16 weeks. Researchers will also be checking how participants feel about their condition and their quality of life, as well as keeping a close eye on any side effects. This will help them decide if upadacitinib could be a good treatment option for these types of lichen in the future.

Key takeaways

This study is testing a new drug (upadacitinib/RINVOQ) for certain types of lichen.
It's a Phase II study, meaning it's an early look at how well the drug works and its safety.
Participants will receive either the drug or a dummy pill (placebo).
The main assessments will happen over 16 weeks, with longer follow-up.
Your health and well-being will be closely monitored throughout.

Who may be eligible?

To be able to join this study, you must be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women are welcome to take part in this research.

Specifically, you or your doctor must have identified that you have erosive mucosal lichen planus or lichen planopilaris. These are the specific types of lichen this study is investigating. If you have a different type of lichen, this study may not be suitable for you.

Further checks will be carried out by the study team to make sure it's safe for you to participate and that the study design is appropriate for your individual health situation. They will explain any other requirements or restrictions in detail.

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 erosive mucosal lichen planus or lichen planopilaris?
Are you comfortable potentially receiving a placebo?
Are you able to attend regular clinic visits and take daily medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medication (upadacitinib) or a dummy pill (placebo) to take. You won't know which one you are receiving, which is a common and important part of clinical trials to ensure fair results. The medication is a tablet taken once a day.

Throughout the study, you will have regular visits to the clinic. At these visits, doctors and nurses will assess your lichen, ask you questions about how you are feeling, and monitor your general health. This will include blood tests, checking your vital signs (like blood pressure and heart rate), and sometimes taking pictures of your skin. You will also be asked to fill out questionnaires about how the condition affects your daily life and your overall well-being.

The initial treatment period where the main results are measured lasts for 16 weeks. However, the study will continue to monitor your health and condition for a longer period, up to 32 weeks, and possibly beyond, to keep track of side effects and changes over time. The total duration of your participation will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in a clinical trial means you might benefit from a new treatment that isn't yet widely available, and you'll be closely monitored by medical professionals. On the other hand, there might be risks associated with the study medication, including side effects that are not yet fully known. Also, you might receive the placebo, meaning you wouldn’t get any active medication for your condition during the study period. You are free 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 'lichen'?

Lichen is a general term for a group of conditions that cause itchy rashes, often on the skin or inside the mouth. This study is looking at specific types that can affect moist linings (mucosal) or the scalp (planopilaris).

What is RINVOQ?

RINVOQ is the brand name for the medication upadacitinib, which is being tested in this study. It's a type of drug that works by calming down an overactive immune system.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medication but doesn't contain any active drug. It helps researchers compare the real drug's effects more accurately.

Will I know if I'm getting the real medication?

No, during the main part of the study, neither you nor your doctor will know if you are receiving the active medication or the placebo. This is to ensure the study results are fair and unbiased.

How long will I be in the study?

The main part of the study where benefits are assessed lasts 16 weeks, but you will be monitored for at least 32 weeks and potentially longer to track follow-up results and safety.