Cardiac SarcoidosisPhase 2NCT06868381
A Trial of Baricitinib in Patients With Cardiac Sarcoidosis
A Phase 2 study testing Baricitinib (LY3009104) 4 mg in people with Cardiac Sarcoidosis, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Sarcoidosis
- What is being tested?
- Baricitinib (LY3009104) 4 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Travis Deal contact
United States1 site
Stanford University
Palo Alto, California, 94304-2210
Angie Aberia, 650-723-8516, aberia@stanford.edu
Matthew C Baker, MD, MS
About this study
Official title: A Phase IIa, Single-Site, Open-Label Trial of Baricitinib in Patients With Cardiac Sarcoidosis
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
- Being tested
- Baricitinib (LY3009104) 4 mg
- Keywords
- baricitinib, sarcoidosis, cardiac sarcoidosis, Janus kinase inhibitor, JAK inhibitor
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib (LY3009104) 4 mgDrug
baricitinib 4 mg tablet taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Baricitinib (LY3009104) 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Percent change in total cardiac metabolic activity on FDG PET-CT
Total cardiac metabolic activity is total lesion glycolysis within the heart
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Proportion of patients with resolution of extracardiac FDG uptake on PET-CT
Measured: 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
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Percent change in total extracardiac metabolic activity on FDG PET-CT
Total extracardiac metabolic activity is total lesion glycolysis of extracardiac disease
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Proportion of patients with resolution of cardiac FDG uptake on PET-CT
Measured: From baseline to 8 weeks and end of follow-up at 28 weeks
Change in sarcoidosis disease activity assessment
Sarcoidosis disease activity assessed with King's Sarcoidosis Questionnaire. Total score range: 0 to 100, with 100 indicating the highest quality of life
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Change in fatigue assessment
Fatigue assessed with FACIT-F. Total score range: 0-52, lower scores correspond with more fatigue
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Change from Baseline in Physician Disease Activity Visual Analogue Scale (VAS)
Physician rates patient's disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Change from Baseline in Patient Disease Activity Visual Analogue Scale (VAS)
Patient rates their disease on a 100 mm VAS. Score range: 0 to 100, higher scores correspond to worse disease state
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in ACE laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in high-sensitivity troponin I laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in NT-proBNP laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in total IgG laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in ESR laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in CRP laboratory assessment
Measured: From baseline to 8 weeks and end of treatment at 16 weeks
Number of participants with safety endpoints of interest
Safety endpoints of interest include hospitalization for cardiac events, implantation of a left ventricular assist device (LVAD), cardiac transplantation, mortality
Measured: From screening to end of follow-up at 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Matthew C. Baker, Stanford University
- Investigators
- Matthew C Baker, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868381
- Sponsor's protocol ID
- 79204
- Status last verified
- Feb 2026
- First submitted
- 3 Mar 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Single-Site, Open-Label Trial of Baricitinib in Patients With Cardiac Sarcoidosis
- ClinicalTrials.gov ID
- NCT06868381
- Acronym / sponsor ID
- 79204
- Conditions
- Cardiac Sarcoidosis
- Keywords
- baricitinib, sarcoidosis, cardiac sarcoidosis, Janus kinase inhibitor, JAK inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| baricitinib + steroid-sparing drug +/- glucocorticoid taper | Experimental | Drug: Baricitinib (LY3009104) 4 mg* 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cardiac sarcoidosis based on one of the following pathways:
Key exclusion criteria (30 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib (LY3009104) 4 mgbaricitinib 4 mg tablet taken orally once daily | Drug | baricitinib + steroid-sparing drug +/- glucocorticoid taper |
Primary outcome
Proportion of patients with resolution of cardiac FDG uptake on PET-CT
Time frame: From baseline to end of treatment at 16 weeks
Resolution of FDG uptake will be determined by the consensus of two blinded nuclear medicine radiologists, in accordance with current SNMMI and ASNC guidelines
17 secondary outcomes
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
Percent change in total cardiac metabolic activity on FDG PET-CT
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
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
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
Percent change in total extracardiac metabolic activity on FDG PET-CT
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Proportion of patients with resolution of cardiac FDG uptake on PET-CT
Time frame: From baseline to 8 weeks and end of follow-up at 28 weeks
Change in sarcoidosis disease activity assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Change in fatigue assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Change from Baseline in Physician Disease Activity Visual Analogue Scale (VAS)
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Change from Baseline in Patient Disease Activity Visual Analogue Scale (VAS)
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in ACE laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in high-sensitivity troponin I laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in NT-proBNP laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in total IgG laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in ESR laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Changes in CRP laboratory assessment
Time frame: From baseline to 8 weeks and end of treatment at 16 weeks
Number of participants with safety endpoints of interest
Time frame: From screening to end of follow-up at 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Travis Deal contact
Matthew C Baker, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib (LY3009104) 4 mg in people with Cardiac Sarcoidosis, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angie Aberia (650-723-8516, aberia@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with resolution of cardiac FDG uptake on PET-CT (time frame: From baseline to end of treatment at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.