A Trial of Baricitinib in Patients With Cardiac Sarcoidosis

NCT06868381 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 79204
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

baricitinib; sarcoidosis; cardiac sarcoidosis; Janus kinase inhibitor; JAK inhibitor

Outcome Measures

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

  From baseline to end of treatment at 16 weeks

Secondary Outcomes (17)

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

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

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

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

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

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

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

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

• Percent change in total extracardiac metabolic activity on FDG PET-CT

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

Study Arms (1)

baricitinib + steroid-sparing drug +/- glucocorticoid taper

EXPERIMENTAL

* 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

Drug: Baricitinib (LY3009104) 4 mg

Interventions

Baricitinib (LY3009104) 4 mg DRUG

baricitinib 4 mg tablet taken orally once daily

baricitinib + steroid-sparing drug +/- glucocorticoid taper

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304-2210, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Matthew C Baker, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Aberia

CONTACT

650-723-8516; aberia@stanford.edu

Travis Deal

CONTACT

tdeal1@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 10, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)