Baricitinib for Cardiac Sarcoidosis

Recruiting in Palo Alto (17 mi)

Overseen byMatthew C Baker, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with active cardiac sarcoidosis, a condition affecting the heart. Participants must be willing to take baricitinib alongside another medication that reduces the need for steroids and commit to regular clinic visits every 2-4 weeks.

Inclusion Criteria

I have been diagnosed with heart sarcoidosis through a PET-CT scan.

I have been diagnosed with cardiac sarcoidosis confirmed by biopsy and PET-CT scans.

I have been diagnosed with cardiac sarcoidosis confirmed by a specific heart scan.

+1 more

Exclusion Criteria

Blood tests at screening meeting specific criteria for hemoglobin, neutrophils, absolute lymphocyte count, and platelets

Current smoking

I do not have a serious infection right now.

+7 more

Participant Groups

The study tests if baricitinib can improve symptoms of cardiac sarcoidosis when taken with steroid-sparing therapy. It measures changes in disease activity using FDG-PET/CT scans over a period of up to 16 weeks.

1Treatment groups

Experimental Treatment

Group I: baricitinib + steroid-sparing drug +/- glucocorticoid taperExperimental Treatment1 Intervention

* Participants will be treated with baricitinib 4 mg daily for up to 16 weeks in combination with a background steroid sparing medication * Participants who are on steroids at the time of enrollment will continue the steroid at a dose of prednisone (or equivalent) ≤ 20mg PO daily at Baseline and complete an 8 week taper of their steroid medication per a standardized protocol