Active — Not RecruitingPhase 2

Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study

United States10 participantsStarted 2024-03-13

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

Change in Oral Disease Severity Scale (ODSS) Scores

Timeframe: Baseline, 24 weeks

Trial details

NCT IDNCT06158113

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Lichen Planus, Oral trials