Health TrialsbyHealthPanel

A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

ConditionCardiac Sarcoidosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorStanford University

About 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 does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Baricitinib (LY3009104) 4 mg

    Drug

    baricitinib 4 mg tablet taken orally once daily

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: baricitinib + steroid-sparing drug +/- glucocorticoid taperExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with resolution of cardiac FDG uptake on PET-CT

Resolution of FDG uptake will be determined by the consensus of two blinded nuclear medicine radiologists, in accordance with current SNMMI and ASNC guidelines

Time frame
From baseline to end of treatment at 16 weeks

Secondary outcomes

1

Percent change in FDG avidity (SUVmax) in the cardiac lesion with greatest FDG avidity on PET-CT

Time frame
From baseline to 8 weeks and end of treatment at 16 weeks
2

Percent change in total cardiac metabolic activity on FDG PET-CT

Total cardiac metabolic activity is total lesion glycolysis within the heart

Time frame
From baseline to 8 weeks and end of treatment at 16 weeks
3

Proportion of patients with resolution of extracardiac FDG uptake on PET-CT

Time frame
From baseline to 8 weeks and end of treatment at 16 weeks
4

Percent change in FDG avidity (SUVmax) in up to six extracardiac lesions on PET-CT

Time frame
From baseline to 8 weeks and end of treatment at 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: