A Phase IIa, Single-Site, Open-Label Trial of Baricitinib in Patients With Cardiac Sarcoidosis
Stanford University
Summary
The goal of this clinical trial is to learn if baricitinib in combination with a background steroid-sparing medication can treat active cardiac sarcoidosis in adults. The main question it aims to answer is: \- In patients with active cardiac sarcoidosis, does treatment with baricitinib improve cardiac sarcoidosis disease activity as assessed by changes on cardiac FDG-PET/CT? Participants will: * Take baricitinib in combination with a steroid-sparing therapy for up to 16 weeks * Visit the clinic every two to four weeks for checkups and tests * Be asked to complete questionnaires to see how they feel on baricitinib and medication diaries to record when they take baricitinib
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Diagnosis of cardiac sarcoidosis based on one of the following pathways: * Histological Diagnosis * Myocardial or extracardiac biopsy demonstrating non-caseating granuloma with no alternative cause identified AND * Abnormal FDG uptake on cardiac PET-CT conducted within six weeks of Screening, in a pattern consistent with active cardiac sarcoidosis AND * Exclusion of other causes for cardiac manifestations * Clinical Diagnosis * One or more of the following is present: * Steroid +/- immunosuppressant responsive cardiomyopathy or heart blo…
Interventions
- DrugBaricitinib (LY3009104) 4 mg
baricitinib 4 mg tablet taken orally once daily
Location
- Stanford UniversityPalo Alto, California