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Janus Kinase (JAK) Inhibitor
Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
Phase 2
Waitlist Available
Led By Aaron R Mangold, MD
Research Sponsored by Aaron R. Mangold
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16, week 28
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Baricitinib, a medication that reduces inflammation, on patients with Cutaneous Lichen Planus, a skin condition with itchy bumps. The drug helps by calming the immune system to lessen skin irritation.
Eligible Conditions
- Lichen Planus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16, week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16, week 28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Physician Global Assessment (PGA) of Skin Overall Response
Secondary study objectives
Change in Modified CAILS Score of the Cutaneous Index Treatment
Change in Overall Skindex-16 Assessment
Change in Pruritus Numerical Rating Scale (NRS)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Escalation Extension GroupExperimental Treatment1 Intervention
Subject that demonstrate a response to the 16 weeks of treatment with 2 mg of Baricitinib (LY3009104), but have not achieved a PGA 0 will receive 4 mg of Baricitinib (LY3009104) for 12 weeks
Group II: Cutaneous LPExperimental Treatment1 Intervention
Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib (LY3009104) 2 mg
2022
Completed Phase 2
~20
Baricitinib (LY3009104) 4 mg
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Aaron R. MangoldLead Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Lichen Planus
12 Patients Enrolled for Lichen Planus
Aaron R Mangold, MDPrincipal InvestigatorMayo Clinic