Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06158113 | Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study | PHASE2 | ACTIVE NOT_RECRUITING | 10 | — | — | Mar 13, 2024 | Sep 1, 2026 | Mar 20, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Baricitinib | EXPERIMENTAL | Participants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Baricitinib 4 milligram Oral Tablet | DRUG | 4 milligrams once daily |
Inclusion Criteria: 1. Voluntarily signed an Institutional Review Board (IRB) approved informed consent. 2. Be at least ≥ 18 years old. 3. Biopsy proven Oral Lichen Planus (OLP) 4. OLP patients with moderate to severe OLP, and must have failed or not tolerated at least one non-corticosteroid system...