What side effects are associated with this type of intervention?

Baricitinib, a Janus kinase (JAK) inhibitor, is being studied for its efficacy in treating moderate to severe Oral Lichen Planus. Known side effects of Baricitinib and similar JAK inhibitors include increased risk of infections, elevated liver enzymes, and changes in blood cell counts. Other common treatments for Oral Lichen Planus, such as corticosteroids, may cause side effects like oral thrush, adrenal suppression, and mucosal atrophy. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for the treatment of Oral Lichen Planus, particularly with JAK inhibitors like Baricitinib. However, JAK inhibitors such as tofacitinib and ruxolitinib have shown promise in treating other inflammatory and autoimmune conditions, which suggests potential efficacy in Oral Lichen Planus. Further studies and clinical trials are necessary to confirm their effectiveness and safety for this specific condition.

What other types of research exist?

Promising novel alternatives to Baricitinib for Oral Lichen Planus patients in 2024 could include PF-04965842, a JAK1 inhibitor, and brepocitinib, a TYK2/JAK1 inhibitor. Both have shown efficacy in related inflammatory conditions and could be potential options pending further clinical trials specific to OLP.

← Back to Search

Janus Kinase (JAK) Inhibitor

Baricitinib for Oral Lichen Planus

Phase 2

Recruiting

Led By Donna Culton, MD, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy proven Oral Lichen Planus (OLP)

Be at least ≥ 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24 weeks

Awards & highlights

Study Summary

This trial is testing baricitinib to evaluate its effectiveness & safety in treating Oral Lichen Planus & its impact on quality of life.

Who is the study for?

Adults with biopsy-proven moderate to severe Oral Lichen Planus who have not responded to at least one systemic treatment. Participants must use effective birth control, maintain oral hygiene, and be on stable doses of certain medications. Excluded are those with low blood counts, high cholesterol or triglycerides, poor liver or kidney function, serious infections or cancer history (with exceptions), risk of blood clots, recent dental procedures, hypersensitivity to JAK inhibitors.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of a drug called Baricitinib for treating Oral Lichen Planus. Patients will take the medication for six months and attend monthly visits where their disease severity and quality of life will be assessed through questionnaires.See study design

What are the potential side effects?

Potential side effects from Baricitinib may include changes in blood counts, liver enzymes alterations indicating potential liver issues, increased cholesterol levels which could affect heart health; also possible are infection risks due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My biopsy confirmed I have Oral Lichen Planus.

Select...

I am 18 years old or older.

Select...

I have moderate to severe oral lichen planus and previous treatments haven't worked.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Oral Disease Severity Scale (ODSS) Scores

Secondary outcome measures

Changes in Quality of Life as assessed with the Chronic Oral Mucosal Disease Questionnaire-26 (COMDQ-26).

Other outcome measures

Estimated response to 24 weeks of treatment with 4mg of baricitinib daily using the Investigator's Global Assessment (IGA).

Trial Design

1Treatment groups

Experimental Treatment

Group I: BaricitinibExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Oral Lichen Planus (OLP) include Janus kinase (JAK) inhibitors like Baricitinib, which block enzymes involved in inflammatory signaling pathways, thereby reducing inflammation. Topical corticosteroids are also frequently used; they suppress the immune response to decrease inflammation. Immunosuppressive agents reduce overall immune system activity. These treatments are essential for OLP patients as they help manage chronic inflammation, alleviate symptoms, and improve quality of life.

Efficacy of treatment for acneiform eruptions related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for non-small cell lung cancer (NSCLC): A protocol of systematic review and network meta-analysis.Analysis of the CDK4/6 Cell Cycle Pathway in Leiomyosarcomas as a Potential Target for Inhibition by Palbociclib.A plea to provide best evidence in trials under sample-size restrictions: the example of pioglitazone to resolve leukoplakia and erythroplakia in Fanconi anemia patients.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,521 Previous Clinical Trials

4,196,624 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,624 Previous Clinical Trials

3,216,919 Total Patients Enrolled

Donna Culton, MD, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

~7 spots leftby Mar 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.