A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

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 block * Unexplained reduced LVEF (\< 40%) and/or segmental wall motion abnormalities not related to coronary artery disease or another defined cause * Unexplained sustained (spontaneous or induced) VT * Mobitz type II 2nd degree heart block or 3rd degree heart block * CT chest and/or FDG PET-CT showing features consistent with pulmonary sarcoidosis and/or hilar lymphadenopathy AND * Abnormal FDG uptake on cardiac PET-CT conducted within 6 weeks of Screening, in a pattern consistent with active cardiac sarcoidosis AND * Exclusion of other causes for cardiac manifestations * Active cardiac sarcoidosis based on abnormal FDG uptake on cardiac PET-CT conducted within six weeks of Screening, in a pattern consistent with active cardiac sarcoidosis * No current treatment with immunosuppressive medications other than a steroid-sparing medication (including methotrexate, leflunomide, azathioprine, or mycophenolate mofetil), and/or prednisone (or equivalent) at a dose of ≤ 20mg daily at Baseline Key Exclusion Criteria: * Receipt of a non-biologic DMARD or immunosuppressive agent other than methotrexate, leflunomide, azathioprine, mycophenolate mofetil, hydroxychloroquine, or glucocorticoids within 28 days prior to screening * Receipt of a bDMARD or tsDMARD, including non-depleting B-cell-directed therapy (eg, belimumab), T cell costimulatory blockade (eg, abatacept), TNF-alpha inhibition (eg, infliximab, adalimumab, etanercept, golimumab, certolizumab pegol), interleukin-6 inhibition (eg, tocilizumab, sarilumab), interleukin-1 inhibition (eg, anakinra), JAK inhibition (eg, tofacitinib, upadacitinib, baricitinib), or other biologic immunomodulatory agent within 28 days prior to screening * Receipt of any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening; receipt of such a B cell-depleting agent in the period 6-12 months prior to screening is exclusionary unless B cell counts have returned to ≥ LLN * History of venous thromboembolism (VTE) or an increased risk for VTE * Current smoking * Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease Study (MDRD) equation * Blood tests at screening that meet any of the following criteria: * Hemoglobin \< 7.5 g/dL * Neutrophils \< 1000/mm3 * Absolute lymphocyte count \< 500/mm3 * Platelets \< 100 x 109/L * Subjects with the following abnormal liver function tests: * Aspartate aminotransferase (AST) \> 2x ULN * Alanine aminotransferase (ALT) \> 2x ULN * Total bilirubin (TBL) \> 2x ULN unless AST, ALT, and hemoglobin are within central laboratory normal range and the patient has a known history of Gilbert syndrome * Active, clinically significant infection at the time of Screening * Active malignancy or history of malignancy that was active within the last 5 years, except as follows: * In situ carcinoma of the cervix following apparently curative therapy \> 12 months prior to screening, * Cutaneous basal cell or squamous cell carcinoma following apparently curative therapy, or * Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent \> 3 years prior to screening and without known recurrence or current treatment