Ongoing Clinical Trials for Oral Lichen Planus
There is currently 1 ongoing clinical trial investigating new treatment options for oral lichen planus, a chronic inflammatory condition that affects the mouth and other mucous membranes. This trial is testing the effectiveness of deucravacitinib, a medication that works by targeting the immune response to reduce inflammation and symptoms. The study is being conducted in Germany and is open to adults aged 18 and older who have confirmed symptoms of the condition.
Clinical trial locations
Study on the Effectiveness of Deucravacitinib for Patients with Lichen Planus
This trial is investigating whether deucravacitinib can help reduce the symptoms and severity of lichen planus, a condition that causes swelling, irritation, and painful lesions in the skin and mucous membranes, particularly in the mouth. The medication works by selectively blocking a protein called TYK2, which is involved in the body’s immune response and inflammation.
Who can participate:
- Adults aged 18 years or older, both men and women
- People with lichen planus confirmed through a medical biopsy (histological test) who currently have active symptoms
- Participants must have a LiPADI Activity Score of 6 or higher, or 3 or higher if symptoms are only in the mouth or other mucosal areas (this score measures how severe the condition is)
- Participants must be able to follow study instructions and attend all required visits
- Written informed consent must be provided, meaning participants agree to join after understanding what the study involves
Who cannot participate:
- People with other skin or mucosal conditions besides lichen planus
- Individuals who fall outside the specified age range for the study
- People who belong to vulnerable populations that may require special protection or care
What the trial involves:
The study lasts approximately 112 days (about 4 months) and involves several visits to monitor progress. At the first visit, researchers conduct a baseline assessment to measure the current severity of symptoms using the LiPADI Activity Score. Participants are then randomly assigned to receive either deucravacitinib (6 mg taken once daily as a tablet) or a placebo, which looks like the medication but contains no active ingredient.
Throughout the trial, participants return for follow-up visits where doctors reassess symptoms, measure changes in the LiPADI Activity Score, and may evaluate other factors such as quality of life and changes in gene expression. The final visit occurs on day 112, when a comprehensive assessment is conducted to determine how much symptoms have changed from the beginning of the study.
Investigational drug:
Deucravacitinib is the medication being tested in this trial. It is taken orally once daily and works by blocking TYK2, an enzyme involved in the immune system’s inflammatory response. By reducing this immune activity, deucravacitinib may help decrease the inflammation, irritation, and painful lesions associated with lichen planus.
Summary
Currently, there is one clinical trial available for patients with oral lichen planus, taking place in Germany. This study focuses on evaluating deucravacitinib, a TYK2 inhibitor that targets the immune response involved in inflammation. The trial is designed to determine whether this medication can effectively reduce disease activity and improve symptoms for people living with this chronic condition. Patients interested in participating must meet specific criteria, including having confirmed symptoms and a certain level of disease severity as measured by the LiPADI Activity Score. The study runs for approximately four months and involves regular monitoring to track changes in symptoms and overall condition.
