← 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

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,191,032 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,620 Previous Clinical Trials

3,216,589 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could Baricitinib negatively impact a patient's health?

"Our assessment of Baricitinib's safety is a 2, as there exists some evidence for its protection but no prior efficacy data."

Answered by AI

Does this research endeavor still accommodate participants?

"As per the information on clinicaltrials.gov, this medical research is not actively seeking participants at present. The study was originally published on January 1st 2024 and edited for the last time on November 27th 2023 - currently supplanted by 18 other trials that are in need of patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06158113.

All > High Point > Greensboro