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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Aug 2026 to Aug 12, 2026v9
  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv8 Show 1 more changeShow less
    • Site details revised
  3. Primary completion date: Dec 2025 to Aug 2026 Completion date: Jan 2026 to Sep 2026v7 Show 1 more changeShow less
    • Completion date: Jan 2026 to Sep 2026
  4. Primary completion date: Mar 2025 to Dec 2025 Completion date: Mar 2025 to Jan 2026v6 Show 1 more changeShow less
    • Completion date: Mar 2025 to Jan 2026
  5. Eligibility criteria shortened, about 11 wordsv5 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Apr 2025 to Mar 2025 Start date changed from estimate of Mar 2024 to Mar 13, 2024v4 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2024 to Mar 13, 2024
  2. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Feb 2026 to Apr 2025 · Start date: Feb 2024 to Mar 2024 · Site details revisedv3 Show 3 more changesShow less
    • Primary and study completion dates: Feb 2026 to Apr 2025
    • Start date: Feb 2024 to Mar 2024
    • Site details revised
  3. Primary and study completion dates: Jan 2026 to Feb 2026 Start date: Jan 2024 to Feb 2024 · Eligibility criteria shortened, about 24 wordsv2 Show 2 more changesShow less
    • Start date: Jan 2024 to Feb 2024
    • Eligibility criteria shortened, about 24 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06158113
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Eli Lilly and Company
Conditions Lichen Planus, Oral, Lichen Planus, Mucosal, Oral Lichen Planus
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov