A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

Launched by STANFORD UNIVERSITY · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called baricitinib to see if it can help treat active cardiac sarcoidosis in adults. Cardiac sarcoidosis is a condition where small clumps of inflammatory cells form in the heart, potentially leading to serious complications. The main goal of the trial is to determine if taking baricitinib alongside another type of medication can improve heart health as seen through specific imaging tests.

To participate, individuals must be diagnosed with active cardiac sarcoidosis and meet certain health criteria, such as having problems with heart function or specific imaging results. Participants will take baricitinib for up to 16 weeks and will visit the clinic every two to four weeks for checkups and tests. They’ll also fill out questionnaires about their health and keep a diary of when they take their medication. This trial is currently not yet recruiting, but it’s an important step in understanding how to better manage this complex heart condition.

Gender

ALL

Eligibility criteria

• 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