Dose Escalation Extension Group for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16, week 28 for reporting.

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 more

Awards & 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