What side effects are associated with this type of intervention?

Common treatments for sarcoidosis, such as glucocorticoids and other immunosuppressive agents, can have a range of side effects. Glucocorticoids, like prednisone, may cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Other immunosuppressive agents, such as methotrexate and azathioprine, can lead to liver toxicity, bone marrow suppression, and gastrointestinal disturbances. These side effects necessitate careful monitoring and individualized treatment plans.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoidosis, particularly those with anti-inflammatory and immunomodulatory properties. Acthar Gel (repository corticotropin injection) is one such treatment, known for its ability to modulate the immune system and reduce inflammation. Other treatments include corticosteroids like prednisone, which are commonly used to manage inflammation in sarcoidosis. Immunosuppressive agents such as methotrexate, azathioprine, and mycophenolate mofetil are also used off-label to treat sarcoidosis by suppressing the immune response. These treatments aim to control symptoms and prevent disease progression.

What other types of research exist?

Promising novel alternatives to Acthar Gel for sarcoidosis patients include: 1) Biologic agents targeting specific inflammatory pathways, such as TNF inhibitors (e.g., infliximab) and IL-17 inhibitors (e.g., secukinumab). 2) JAK inhibitors, which modulate the immune response by inhibiting Janus kinase enzymes. 3) Anti-fibrotic agents like pamrevlumab, which have shown potential in treating fibrotic lung diseases. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Corticosteroid

Acthar Gel for Sarcoidosis (Acthar Trial)

Phase 4

Recruiting

Led By Laura Koth, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement

Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months

Awards & highlights

Acthar Trial Summary

This trial will test whether Acthar gel can improve symptoms and lung function in people with sarcoidosis, and whether it is linked with lower levels of biomarkers like CXCL9.

Who is the study for?

This trial is for individuals with biopsy-proven sarcoidosis affecting the lungs, who haven't responded well to or can't tolerate standard treatments like prednisone. It's not open to recent surgery patients, smokers, those with osteoporosis, cancer, heart failure, high blood pressure that isn't managed, chronic infections (like TB), stomach ulcers or other lung diseases.Check my eligibility

What is being tested?

The study is examining if Acthar gel improves symptoms and lung function in sarcoidosis patients. It also looks at whether levels of a blood marker called CXCL9 change with treatment. The goal is to see if this marker can predict how well the drug works.See study design

What are the potential side effects?

Acthar gel may cause side effects such as increased blood pressure and sugar levels, mood swings, weight gain due to fluid retention, digestive issues and risk of infection due to its immune system effects.

Acthar Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have sarcoidosis confirmed by biopsy with lung involvement.

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My body did not respond well to treatments like prednisone or methotrexate.

Acthar Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decrease in blood CXCL9 levels by 50%

Secondary outcome measures

Improvement in FVC by 5% of predicted

Improvement in dyspnea score

Acthar Trial Design

1Treatment groups

Experimental Treatment

Group I: Acthar gelExperimental Treatment1 Intervention

After a 4-week period of baseline monitoring, Acthar gel will be administered by intramuscular or subcutaneous injection. Initial dosing will be 40 U every 72 hours (or twice per week) for 4 weeks. Dosage will then be increased to 80 U with similar frequency for 8 weeks and up to 16 weeks.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sarcoidosis treatments often target inflammation and immune system modulation. Glucocorticoids, like prednisone, reduce inflammation by suppressing the immune response, which helps alleviate symptoms and prevent organ damage. TNF inhibitors, such as infliximab, block tumor necrosis factor-alpha, a cytokine involved in granuloma formation, thus reducing inflammation and granuloma development. Immunosuppressive agents like methotrexate inhibit immune cell proliferation, further controlling the immune response. These treatments are crucial for Sarcoidosis patients as they help manage symptoms, prevent disease progression, and improve quality of life by targeting the underlying inflammatory and immune processes.