Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor: Aaron R. Mangold
Study ID: NCT05188521
Phase: PHASE2
Status: Completed

Conditions

Cutaneous Lichen Planus

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Baricitinib (LY3009104) 2 mg — DRUG
2 mg orally administered once daily for 16 weeks
Baricitinib (LY3009104) 4 mg — DRUG
4 mg orally administered once daily for 12 weeks

Study Details

This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).

Key Dates

Start date: Jan 11, 2022
Status verified: May 2024
Primary completion: May 17, 2023
Completion: May 17, 2023

Study Design

Enrollment: 12 participants (actual)
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Arms

Experimental: Cutaneous LP
Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period
Experimental: Dose Escalation Extension Group
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

Primary Outcome Measure

Physician Global Assessment (PGA) of Skin Overall Response [ Time Frame: Week 16 ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Mayo Clinic in Arizona	Scottsdale	Arizona	85259	-

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Mayo Clinic in Arizona· Scottsdale, AZ