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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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:
Participants will be required to come in to monthly visits for up to eight months. During visits, participants will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Participants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib 4 milligram Oral Tablet | Drug | 4 milligrams once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated response to 24 weeks of treatment with 4mg of baricitinib daily using the Investigator's Global Assessment (IGA). | The Investigator Global Assessment (IGA) represents the study doctor's overall assessment of the extent of disease. It assesses changes in symptomatic Oral Lichen Planus and it is meant to be a well-defined and reliable tool to measure disease severity in clinical studies. This tool assigns a score of 0-4 depending on how severe the disease is, with higher scores meaning worse disease. Overall change from baseline to week 24 reported. |
Inclusion Criteria:
Exclusion Criteria:
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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Donna Culton, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Dermatology and Skin Cancer Center | Chapel Hill | North Carolina | 27516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17711534 | Background | 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. | |
| 32363637 | Background | Wiriyakijja 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. |
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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.
Beginning 9 and continuing for 36 months after publication.
Data will be made available to investigators who have 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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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Baseline, 24 weeks |
| Baseline, 24 weeks |
| 32018031 | Background | Damsky 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. |
| 31554739 | Background | Shao 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |