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.

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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

Must not have

Hypersensitivity to Janus kinase (JAK) inhibitors

Subjects with any serious concomitant illness that is anticipated to require the use of systemic corticosteroids >10mg daily or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing baricitinib, a drug that might help people with painful mouth sores from Oral Lichen Planus. It aims to see if the drug can improve their condition and quality of life, and what side effects it might have. Participants will take the drug for several months and visit the clinic regularly for evaluations. Baricitinib has been evaluated for other conditions and has shown potential as a treatment.

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.

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.

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

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My biopsy confirmed I have Oral Lichen Planus.

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to JAK inhibitors.

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I do not have a serious illness requiring frequent steroid use or close monitoring.

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I do not need major surgery within the next 8 weeks or during the study.

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I have no unhealed wounds in my mouth from recent surgery or treatments.

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My cholesterol has never been above 400mg/dL or caused serious health issues.

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My kidney function is below the required level for the study.

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I currently have or recently had a serious infection.

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I have a history of blood clots or stroke, or I'm at high risk for blood clots.

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I have never had any form of mouth cancer.

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I have had a gastrointestinal perforation in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Oral Disease Severity Scale (ODSS) Scores

Secondary study objectives

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

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 13Eligibility 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.