Lichen Planus, OralPhase 2NCT06158113
Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study
A Phase 2 study testing Baricitinib 4 milligram Oral Tablet in people with Lichen Planus, Oral and Lichen Planus, Mucosal, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus, Oral, Lichen Planus, Mucosal, Oral Lichen Planus
- What is being tested?
- Baricitinib 4 milligram Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2024to 9 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed an Institutional Review Board (IRB) approved informed consent.
- Be at least ≥ 18 years old.
- Biopsy proven Oral Lichen Planus (OLP)
- OLP patients with moderate to severe OLP, and must have failed or not tolerated at least one non-corticosteroid systemic treatment for OLP (such as metronidazole, hydroxychloroquine, methotrexate, mycophenolate mofetil, azathioprine, acitretin, rituximab, thalidomide, cyclosporine, apremilast, dapsone or systemic calcineurin inhibitor).
- Subjects should practice daily oral hygiene (defined as brushing teeth twice daily) and be willing to maintain their routine oral hygiene procedure during study participation.
- Willingness to abstain from certain mouth products during the course of the study
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- Must be willing to not receive any live vaccines during and up to 30 days after the end of treatment.
- Vaccination status of subjects should be reviewed prior to study entry. Subjects must be encouraged to receive non-live vaccines following centers of disease control (CDC) guidelines for vaccination of those ≥18 years of age to prevent infectious disease 30 days before baseline.
- Individuals who can potentially become pregnant must have a negative urine pregnancy test at screening and must be confirmed negative at time of enrollment (baseline visit).
- Individuals who can potentially become pregnant must agree to use a highly effective form of birth control when engaging in sexual intercourse with a male partner during the study and for 30 days after the last dose.
- Male subjects must be willing to use a highly effective method of contraception or practice true abstinence from sexual intercourse during the study and for 30 days after the last dose.
- Must be able to comply with study instructions and attend all study visits.
Who cannot join
- Absolute lymphocyte count <750cells/mm^3 within 30 days of starting study drug
- Absolute neutrophil count <1200cells/mm^3 within 30 days of starting study drug
- Hemoglobin <10.0g/dL within 30 days of starting study drug
- Platelet count <100,000 cells/mm^3 within 30 days of starting study drug
- Fasting cholesterol levels >400mg/dL or >10.34mmol/L within 30 days of starting study drug or levels that may have required hospitalization, caused pancreatitis, or became life threatening.
- Serum triglycerides >500mg/dL or >5.7mmol/L within 30 days of starting study drug.
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- Chronic liver disease with severe hepatic impairment as defined in the protocol.
- Inadequate renal function tests defined as an estimated glomerular filtration rate (eGFR) based on the most recent available creatinine using the chronic kidney disease epidemiology collaboration equation (CKD-EPI) creatinine 2009 equation of <60 millimeters/minute/1.73 meters squared (m^2) within 30 days of starting study drug.
- Ongoing active or recent clinically serious fungal, bacterial, viral, or parasitic infection.
- History of gastrointestinal perforation
- History of heart attack or significant cardiovascular risk that in the investigator's judgement, the risks of the subject participating in the study is greater than its benefit.
- Hypercoagulable state such as history of deep vein thromboembolism (VTE) or stroke OR are considered at high risk of VTE.
- History of cancer (except treated cutaneous basal cell carcinoma (BCC), cutaneous squamous cell carcinoma in situ (cSCCis) and in situ cervical cancer) unless it can be documented that the patient has been in a disease-free state for at least 5 years for high grade cancers with the following exception:
- In case of clinical suspicion of malignancy in the oral cavity, a patient can only be included after an excluding biopsy
- Any history of squamous cell carcinoma or melanoma (even if resected) in the mouth, as well as history of other non-squamous cell carcinoma (e.g., sarcoma, salivary gland tumors) in the mouth are excluded.
- Subjects who may have signs of lymphoproliferative disease, such as lymphadenopathy or splenomegaly unless stable for the last 5 years
- Professional dental cleaning within 2 weeks prior to baseline
- Patient with any un-healed oral surgery (including recent diagnostic biopsies, if applicable) or oral laser therapeutic wound(s) at baseline visit
- Subjects must have failed at least one systemic therapy for OLP to be included in the study. Appropriate washout for past medications received and stable doses for other medications should be followed as outlined in the protocol.
- Hypersensitivity to Janus kinase (JAK) inhibitors.
- Subjects with any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring (e.g., unstable chronic asthma)
- Subjects who require major surgery within 8 weeks of baseline and/or during the study are excluded.
- Current participation in another clinical study and/or having received treatment with any non-marketed / investigational medicinal product (drug substance or medical device) within 30 days prior to baseline or 5.5 half-lives, whichever is longer.
- Intention to become pregnant during the study period (30 days after stopping investigational product)
- Intention to breastfeed until 30 days after stopping investigational product.
- Any other condition that in the investigator's judgement the subject's risks are greater than the benefit from participating in the study or may interfere with interpretation of data.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Dermatology and Skin Cancer Center
Chapel Hill, North Carolina, 27516
About this study
Official title: Efficacy and Safety of Baricitinib for the Treatment of Oral Lichen Planus: A Proof-of-Concept Study
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?
Read more
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
- Being tested
- Baricitinib 4 milligram Oral Tablet
- Keywords
- Jak inhibitor, Janus kinase inhibitor
- Medical subject headings
- Lichen Planus, Oral, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 milligram Oral TabletDrug
Also called Olumiant
4 milligrams once daily
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Participants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks. Receives: Drug: Baricitinib 4 milligram Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Disease Severity Scale (ODSS) Scores
The Oral Disease Severity Scale (ODSS) is a validated tool to assess severity of Oral Lichen Planus. For scoring, the oral cavity is divided into 17 sites and assigned three different scores. A site score, which captures disease extent, a severity score, and an activity score which is obtained by multiplying the site and severity scores. Independently study participants are asked to fill in a numerical rating scale graded from 0-10, with zero meaning no pain and 10 being the worst imaginable pain felt within the last 4 weeks. Scores are added together and range from 0-106, with higher scores meaning more severe disease. Overall change from baseline to week 24 will be reported.
Measured: Baseline, 24 weeks
Secondary outcomes (1)
Changes in Quality of Life as assessed with the Chronic Oral Mucosal Disease Questionnaire-26 (COMDQ-26).
The Chronic Oral Mucosal Disease Questionnaire-26 (COMDQ-26) is a 26-item validated survey specific to assess changes in quality of life in patients with Oral Lichen Planus. The total score of the COMDQ-26 ranges from 0-104 with higher scores indicating worse quality of life. The number of participants that achieve at least a 9 point reduction in their scores from baseline will be reported.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start13 Mar 2024
- Primary completion12 Aug 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Donna Culton, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158113
- Sponsor's protocol ID
- 22-0969
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Publications
Escudier M, Ahmed N, Shirlaw P, Setterfield J, Tappuni A, Black MM, Challacombe SJ. A scoring system for mucosal disease severity with special reference to oral lichen planus. Br J Dermatol. 2007 Oct;157(4):765-70. doi: 10.1111/j.1365-2133.2007.08106.x. Epub 2007 Aug 17.
PubMed 17711534Wiriyakijja P, Porter S, Fedele S, Hodgson T, McMillan R, Shephard M, Ni Riordain R. Meaningful improvement thresholds in measures of pain and quality of life in oral lichen planus. Oral Dis. 2020 Oct;26(7):1464-1473. doi: 10.1111/odi.13379. Epub 2020 May 26.
PubMed 32363637Damsky W, Wang A, Olamiju B, Peterson D, Galan A, King B. Treatment of severe lichen planus with the JAK inhibitor tofacitinib. J Allergy Clin Immunol. 2020 Jun;145(6):1708-1710.e2. doi: 10.1016/j.jaci.2020.01.031. Epub 2020 Feb 1. No abstract available.
PubMed 32018031Shao S, Tsoi LC, Sarkar MK, Xing X, Xue K, Uppala R, Berthier CC, Zeng C, Patrick M, Billi AC, Fullmer J, Beamer MA, Perez-White B, Getsios S, Schuler A, Voorhees JJ, Choi S, Harms P, Kahlenberg JM, Gudjonsson JE. IFN-gamma enhances cell-mediated cytotoxicity against keratinocytes via JAK2/STAT1 in lichen planus. Sci Transl Med. 2019 Sep 25;11(511):eaav7561. doi: 10.1126/scitranslmed.aav7561.
PubMed 31554739
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Baricitinib for the Treatment of Oral Lichen Planus: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT06158113
- Acronym / sponsor ID
- 22-0969
- Keywords
- Jak inhibitor, Janus kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib 4 milligram Oral TabletParticipants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily signed an Institutional Review Board (IRB) approved informed consent.
- Be at least ≥ 18 years old.
- Biopsy proven Oral Lichen Planus (OLP)
- OLP patients with moderate to severe OLP, and must have failed or not tolerated at least one non-corticosteroid systemic treatment for OLP (such as metronidazole, hydroxychloroquine, methotrexate, mycophenolate mofetil, azathioprine, acitretin, rituximab, thalidomide, cyclosporine, apremilast, dapsone or systemic calcineurin inhibitor).
- Subjects should practice daily oral hygiene (defined as brushing teeth twice daily) and be willing to maintain their routine oral hygiene procedure during study participation.
Key exclusion criteria (26 listed)
- Absolute lymphocyte count <750cells/mm^3 within 30 days of starting study drug
- Absolute neutrophil count <1200cells/mm^3 within 30 days of starting study drug
- Hemoglobin <10.0g/dL within 30 days of starting study drug
- Platelet count <100,000 cells/mm^3 within 30 days of starting study drug
- Fasting cholesterol levels >400mg/dL or >10.34mmol/L within 30 days of starting study drug or levels that may have required hospitalization, caused pancreatitis, or became life threatening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib 4 milligram Oral TabletAlso: Olumiant4 milligrams once daily | Drug | Baricitinib |
Primary outcome
Change in Oral Disease Severity Scale (ODSS) Scores
Time frame: Baseline, 24 weeks
The Oral Disease Severity Scale (ODSS) is a validated tool to assess severity of Oral Lichen Planus. For scoring, the oral cavity is divided into 17 sites and assigned three different scores. A site score, which captures disease extent, a severity score, and an activity score which is obtained by multiplying the site and severity scores. Independently study participants are asked to fill in a numerical rating scale graded from 0-10, with zero meaning no pain and 10 being the worst imaginable pain felt within the last 4 weeks. Scores are added together and range from 0-106, with higher scores meaning more severe disease. Overall change from baseline to week 24 will be reported.
1 secondary outcome
Changes in Quality of Life as assessed with the Chronic Oral Mucosal Disease Questionnaire-26 (COMDQ-26).
Time frame: Baseline, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 17711534Escudier M, Ahmed N, Shirlaw P, Setterfield J, Tappuni A, Black MM, Challacombe SJ. A scoring system for mucosal disease severity with special reference to oral lichen planus. Br J Dermatol. 2007 Oct;157(4):765-70. doi: 10.1111/j.1365-2133.2007.08106.x. Epub 2007 Aug 17.
- Background: PubMed 32363637Wiriyakijja P, Porter S, Fedele S, Hodgson T, McMillan R, Shephard M, Ni Riordain R. Meaningful improvement thresholds in measures of pain and quality of life in oral lichen planus. Oral Dis. 2020 Oct;26(7):1464-1473. doi: 10.1111/odi.13379. Epub 2020 May 26.
- Background: PubMed 32018031Damsky W, Wang A, Olamiju B, Peterson D, Galan A, King B. Treatment of severe lichen planus with the JAK inhibitor tofacitinib. J Allergy Clin Immunol. 2020 Jun;145(6):1708-1710.e2. doi: 10.1016/j.jaci.2020.01.031. Epub 2020 Feb 1. No abstract available.
- Background: PubMed 31554739Shao S, Tsoi LC, Sarkar MK, Xing X, Xue K, Uppala R, Berthier CC, Zeng C, Patrick M, Billi AC, Fullmer J, Beamer MA, Perez-White B, Getsios S, Schuler A, Voorhees JJ, Choi S, Harms P, Kahlenberg JM, Gudjonsson JE. IFN-gamma enhances cell-mediated cytotoxicity against keratinocytes via JAK2/STAT1 in lichen planus. Sci Transl Med. 2019 Sep 25;11(511):eaav7561. doi: 10.1126/scitranslmed.aav7561.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Culton, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib 4 milligram Oral Tablet in people with Lichen Planus, Oral and Lichen Planus, Mucosal, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Disease Severity Scale (ODSS) Scores (time frame: Baseline, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.