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Baricitinib 4 milligram

Phase 2

Lichen Planus, Oral | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: Sep 1, 2026

Target and mechanism

Molecular targetJAK1, JAK2
Target classInhibitor
ModalitySmall molecule

Also known as Baricitinib 4 milligram Oral Tablet

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Baricitinib 4 milligram · 1 trial · 3 indications

Phase 2 1
NCT06158113Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept StudyLichen Planus, Oral
ACTIVE NOT_RECRUITING10 Analytics
PHASE2ACTIVE NOT_RECRUITING
Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study
Lichen Planus, OralUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Oral Disease Severity Scale (ODSS) Scores
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.

Secondary Endpoints

Changes in Quality of Life as assessed with the Chronic Oral Mucosal Disease Questionnaire-26 (COMDQ-26).
Baseline, 24 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BaricitinibEXPERIMENTALParticipants will be asked to take 4mg of baricitinib by mouth daily for up to 24 weeks.

Interventions

NameTypeDescription
Baricitinib 4 milligram Oral TabletDRUG4 milligrams once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 1, 2026NCT06158113primaryCompletionDate: changed
LOWSep 1, 2026NCT06158113primaryCompletionDate: changed

Frequently asked questions about Baricitinib 4 milligram

What is Baricitinib 4 milligram used for?

Baricitinib 4 milligram is used for oral lichen planus, a chronic inflammatory condition affecting the mouth. It is being studied as a treatment for this dermatological indication. The drug is currently in Phase 2 clinical development for this use.

What does Baricitinib 4 milligram target?

Baricitinib 4 milligram targets kinases, as it belongs to the -tinib class of kinase inhibitors. Kinases are enzymes involved in cell signaling and inflammation, and inhibiting them may help reduce the inflammatory response associated with oral lichen planus.

Who makes Baricitinib 4 milligram?

Baricitinib 4 milligram is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in oral lichen planus.

What phase is Baricitinib 4 milligram in?

Baricitinib 4 milligram is in Phase 2 clinical development for oral lichen planus. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing trial is a proof-of-concept study to assess its potential efficacy and safety.

What clinical trials is Baricitinib 4 milligram in?

Baricitinib 4 milligram is being studied in a Phase 2 clinical trial with the identifier NCT06158113. This trial, titled 'Efficacy and Safety of Baricitinib in Oral Lichen Planus: a Proof-of-Concept Study,' is active but not recruiting participants. It is an uncontrolled study enrolling 10 participants in the United States.

Is Baricitinib 4 milligram the same as Baricitinib 4 milligram Oral Tablet?

Yes, Baricitinib 4 milligram is the same as Baricitinib 4 milligram Oral Tablet. The oral tablet formulation is the form being studied in clinical trials for oral lichen planus. Both names refer to the same drug product.