A Trial of Baricitinib in Patients With Cardiac Sarcoidosis (NCT06868381) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Trial of Baricitinib in Patients With Cardiac Sarcoidosis
United States10 participantsStarted 2026-04-01
Plain-language 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
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 methotrexat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with resolution of cardiac FDG uptake on PET-CT
Timeframe: From baseline to end of treatment at 16 weeks