Baricitinib (LY3009104) in the Treatment of Cutaneous Lichen Planus
- Conditions
- Cutaneous Lichen Planus
- Interventions
- Registration Number
- NCT05188521
- Lead Sponsor
- Aaron R. Mangold
- Brief Summary
This research study is evaluating the safety and efficacy of Baricitinib in treating Cutaneous Lichen Planus (LP).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cutaneous LP Baricitinib (LY3009104) 2 mg Subjects with a diagnosis of cutaneous LP will receive Baricitinib (LY3009104) for a 16 weeks treatment period Dose Escalation Extension Group Baricitinib (LY3009104) 4 mg 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 Measures
Name Time Method Physician Global Assessment (PGA) of Skin Overall Response Week 16 Measured by Physician Global Assessment (PGA) of skin by grade. The assessment ranges from Grade 0 (completely clear with no evidence of disease; 100% improvement) to Grade 6 (worse than at baseline evaluation by ≥25%; more progressive disease).
- Secondary Outcome Measures
Name Time Method Change in Skin Lesion Count Week 16, Week 28 Change in the number of subject's skin lesions from Week 16 to Week 28.
Change in Pruritus Numerical Rating Scale (NRS) Week 16, Week 28 The Pruritus NRS is self-reported single question that asks "how severe itching has been over the last 24 hours". The response uses a scale of 0 (no itching) to 10 (severe itching). The higher the score, the worse the itching.
Change in Overall Skindex-16 Assessment Week 16, Week 28 This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Change in Modified CAILS Score of the Cutaneous Index Treatment Week 16, Week 28 Measured by Modified CAILS-Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS). The area of the lesion is measured with digital planimetry. Lesion size by square centimeter is graded on a scale of 0 to 18, where 0 is no measurable area and 18 is greater than 300 centimeters. The higher the score the larger the lesion.
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States