Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study (NCT06158113) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study
United States10 participantsStarted 2024-03-13
Plain-language 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 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Oral Disease Severity Scale (ODSS) Scores
. 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.
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.