A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

NCT ID: NCT06868381

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-04-01

Brief 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

Conditions

Cardiac Sarcoidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

baricitinib + steroid-sparing drug +/- glucocorticoid taper

• 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

Group Type: EXPERIMENTAL

Baricitinib (LY3009104) 4 mg

Intervention Type: DRUG

baricitinib 4 mg tablet taken orally once daily

Interventions

Baricitinib (LY3009104) 4 mg

baricitinib 4 mg tablet taken orally once daily

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Matthew C. Baker

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew C Baker, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Central Contacts

Angie Aberia

Role: CONTACT

aberia@stanford.edu

650-723-8516

Travis Deal

Role: CONTACT

tdeal1@stanford.edu

Facility Contacts

Angie Aberia

Role: primary

aberia@stanford.edu

650-723-8516

Other Identifiers

79204

Identifier Type: -

Identifier Source: org_study_id