Efficacy and Safety of Baricitinib for the Treatment of Oral Lichen Planus: A Proof-of-Concept Study
The goal of this clinical trial is to learn the effects of baricitinib (the study drug) in patients with Oral Lichen Planus. The main questions it aims to answer are: * What is the efficacy of baricitinib in treating moderate to severe Oral Lichen Planus? * Can baricitinib treatment in Oral Lichen Planus change quality of life? * What side effects do patients with Oral Lichen Planus experience when treated with baricitinib? Participants will be required to come in to monthly visits for up to eight months. During visits, participants will be: * Evaluated for the extent of their disease * Asked to fill out a questionnaire about their quality of life * Given baricitinib for them to take at home for six months * Evaluated for any potential side experienced while on treatment * Asked to return 1 month after completing treatment
• Voluntarily signed an Institutional Review Board (IRB) approved informed consent.
• Be at least ≥ 18 years old.
• Biopsy proven Oral Lichen Planus (OLP)
• OLP patients with moderate to severe OLP, and must have failed or not tolerated at least one non-corticosteroid systemic treatment for OLP (such as metronidazole, hydroxychloroquine, methotrexate, mycophenolate mofetil, azathioprine, acitretin, rituximab, thalidomide, cyclosporine, apremilast, dapsone or systemic calcineurin inhibitor).
• Subjects should practice daily oral hygiene (defined as brushing teeth twice daily) and be willing to maintain their routine oral hygiene procedure during study participation.
• Willingness to abstain from certain mouth products during the course of the study
• Must be willing to not receive any live vaccines during and up to 30 days after the end of treatment.
• Vaccination status of subjects should be reviewed prior to study entry. Subjects must be encouraged to receive non-live vaccines following centers of disease control (CDC) guidelines for vaccination of those ≥18 years of age to prevent infectious disease 30 days before baseline.
• Individuals who can potentially become pregnant must have a negative urine pregnancy test at screening and must be confirmed negative at time of enrollment (baseline visit).
⁃ Individuals who can potentially become pregnant must agree to use a highly effective form of birth control when engaging in sexual intercourse with a male partner during the study and for 30 days after the last dose.
⁃ Male subjects must be willing to use a highly effective method of contraception or practice true abstinence from sexual intercourse during the study and for 30 days after the last dose.
⁃ Must be able to comply with study instructions and attend all study visits.