Baricitinib for Cardiac Sarcoidosis

Overseen By Angie Aberia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must be taking: Steroid-sparing therapy

Must not be taking: Biologic DMARDs, JAK inhibitors

Disqualifiers: VTE history, Smoking, Renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug baricitinib, combined with a steroid-sparing medication, can treat active cardiac sarcoidosis. In this condition, clusters of immune cells form in the heart and affect its function. Participants will take baricitinib for up to 16 weeks and visit the clinic regularly for checkups. The trial is best suited for adults with a confirmed diagnosis of active cardiac sarcoidosis, especially those experiencing symptoms like heart block or unexplained heart problems not caused by other heart diseases. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking any immunosuppressive medications other than specific steroid-sparing medications or prednisone at a low dose. If you are on other immunosuppressive drugs, you may need to stop them at least 28 days before screening.

Is there any evidence suggesting that baricitinib is likely to be safe for humans?

Research has shown that baricitinib is generally safe for people. In a previous study, serious heart problems occurred less frequently with baricitinib compared to tofacitinib, suggesting that baricitinib might be better for heart health.

Another review examined safety data from over 2,500 patients using baricitinib for a different condition. The results indicated that baricitinib was safe, with no unexpected side effects over a long period. Although these studies focused on other conditions, they offer some reassurance about the safety of baricitinib for treating cardiac sarcoidosis in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for cardiac sarcoidosis, such as corticosteroids and immunosuppressants, work by broadly dampening the immune system. But baricitinib works differently, targeting a specific part of the immune response known as the JAK-STAT pathway. This targeted approach could mean fewer side effects and a more effective way to control inflammation. Researchers are excited about baricitinib because it offers a more precise way to manage the condition while potentially reducing reliance on steroids, which can have long-term side effects.

What evidence suggests that baricitinib might be an effective treatment for cardiac sarcoidosis?

Research has shown that baricitinib, initially used for rheumatoid arthritis, may help reduce disease activity. Although limited studies have focused on cardiac sarcoidosis specifically, its success in controlling inflammation in other conditions suggests potential benefits. Baricitinib has effectively helped individuals achieve remission or low disease activity in various inflammatory diseases. In this trial, participants will receive baricitinib combined with a steroid-sparing medication to better control cardiac sarcoidosis while minimizing steroid side effects. Researchers believe baricitinib might reduce heart inflammation, potentially improving symptoms and disease activity. ^{1 3 4 6 7}

Who Is on the Research Team?

Matthew C Baker, MD, MS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive baricitinib in combination with a steroid-sparing therapy for up to 16 weeks

16 weeks

Clinic visits every two to four weeks for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Baricitinib

Trial Overview 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.

How Is the Trial Designed?

Group I: baricitinib + steroid-sparing drug +/- glucocorticoid taper Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a two-year study of 44 patients with rheumatoid arthritis, both baricitinib and tofacitinib were found to be effective in reducing disease activity, with baricitinib showing slightly greater reductions in the DAS28 scale and pain levels over 12 months.

Both medications had similar safety profiles, with low rates of adverse reactions (10% for baricitinib and 12.5% for tofacitinib) and comparable treatment discontinuation rates due to loss of effectiveness, indicating they are both viable options for managing rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice. González-Freire, L., Giménez-Candela, RM., Castro-Luaces, S., et al.[2021]

Acalabrutinib, a second-generation BTK inhibitor, has shown high overall response rates of 96% in treatment-naive and 93% in relapsed/refractory chronic lymphocytic leukemia (CLL) patients, indicating its efficacy as a treatment option.

The safety profile of acalabrutinib is generally favorable, with most adverse effects being mild to moderate (grade 1-2), and only limited severe toxicities reported, suggesting it may be a safer alternative to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. Khan, Y., O'Brien, S.[2019]

Baricitinib, an oral JAK1/JAK2 inhibitor, demonstrated an acceptable safety profile in 514 Japanese patients with rheumatoid arthritis over a median exposure of 1.7 years, with no deaths reported and manageable adverse events.

The most notable safety concern was an increased incidence of herpes zoster, although overall safety was comparable to that of RA patients in a broader integrated database, indicating that baricitinib is an effective treatment option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials. Harigai, M., Takeuchi, T., Smolen, JS., et al.[2021]

Baricitinib, an oral JAK1/JAK2 inhibitor, has a safety profile that reflects the inherent risks of the diseases it treats, with higher rates of infections and serious adverse events observed in patients with rheumatic diseases compared to those with dermatological conditions.

In clinical studies, the incidence of major adverse cardiovascular events (MACE) with baricitinib was lower than that seen with tofacitinib and comparable to tumor necrosis factor inhibitors, indicating a favorable safety profile, especially in hospitalized COVID-19 patients treated for up to 14 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Safety Outcomes from Clinical Trials of Baricitinib in Rheumatology, Dermatology and COVID-19. Bieber, T., Feist, E., Irvine, AD., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-2-cardiac-sarcoidosis-3-2025-320d9

Baricitinib for Cardiac Sarcoidosis · Info for Participants In a two-year study of 44 patients with rheumatoid arthritis, both baricitinib and tofacitinib were found to be effective in reducing disease activity, with ...

2. trial.medpath.com trial.medpath.com/clinical-trial/73ba14a9bdc43e15/nct06868381-baricitinib-cardiac-sarcoidosis-trial

A 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 ...

3. med.stanford.edu med.stanford.edu/mosslab/research/_jcr_content/main/clinicaltrials.html?ctid=NCT06868381&conditionId=&serviceLineId=&condition=&alpha=a

A 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8964893/

Real-World Treatment Patterns and Clinical Outcomes of ... In them, baricitinib proved to be effective not only to achieve remission or low activity of the disease. Also in the control of Patient ...

5. thorax.bmj.com thorax.bmj.com/content/80/10/702

Systematic review and meta-analysis of the efficacy ... 33 34 Our data synthesis provided some evidence of beneficial effects across both pulmonary and extrapulmonary sarcoidosis with infliximab, adalimumab, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9443639/

A Review of Safety Outcomes from Clinical Trials ... The review of baricitinib safety in patients with AD utilised the AD integrated safety data set that included 2531 patients, followed for ...

7. academic.oup.com academic.oup.com/bjd/article/188/2/218/6821292

Integrated safety analysis of baricitinib in adults with severe ... Objectives. To report safety data for baricitinib in patients with severe AA from two clinical trials including long-term extension periods.