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

Conditions

• Lichen Planus, Mucosal
• Lichen Planus, Oral
• Oral Lichen Planus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Baricitinib 4 milligram Oral Tablet — DRUG
  4 milligrams once daily

Study Details

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

Key Dates

Start date

Mar 13, 2024

Status verified

Mar 2026

Primary completion

Aug 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Baricitinib
  Participants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks.

Primary Outcome Measure

Change in Oral Disease Severity Scale (ODSS) Scores [ Time Frame: Baseline, 24 weeks ]

Locations (1)

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