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

NCT06158113 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-20

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Baricitinib 4 milligram Oral Tablet

4 milligrams once daily

Sponsors & Collaborators

Principal Investigators

  • Donna Culton, MD, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158113 on ClinicalTrials.gov