14 Participants Needed

Acthar Gel for Sarcoidosis

(Acthar Trial)

LK
Overseen ByLaura Koth, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing Acthar gel, a medication that reduces inflammation, in patients with pulmonary sarcoidosis. The goal is to see if it improves lung function and symptoms by calming the immune system. Researchers will also check if certain blood markers decrease as symptoms improve.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be intolerant of or not responding to certain immunosuppressive drugs like prednisone or methotrexate.

Is Acthar Gel safe for humans?

Acthar Gel has been studied for safety in various inflammatory diseases, including sarcoidosis, and many studies have shown it to be safe for patients who cannot tolerate standard treatments. However, like any medication, it may have side effects, and its safety profile has been evaluated in over 500 publications.12345

How is Acthar Gel different from other drugs for sarcoidosis?

Acthar Gel is unique because it acts as a steroid-sparing therapy, meaning it can reduce the need for long-term use of corticosteroids, which often have significant side effects. It works by activating specific receptors in the body to help manage inflammation, making it a novel option for patients who cannot tolerate standard treatments.13467

What data supports the effectiveness of the drug Acthar Gel for treating sarcoidosis?

Research suggests that Acthar Gel can reduce the need for corticosteroids (a type of medication often used to reduce inflammation) in sarcoidosis patients, which may help avoid the side effects associated with long-term steroid use. Additionally, Acthar Gel has been studied for its effectiveness in treating various inflammatory diseases, showing promise when other treatments were not effective.12346

Who Is on the Research Team?

LK

Laura Koth, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have sarcoidosis confirmed by biopsy with lung involvement.
My body did not respond well to treatments like prednisone or methotrexate.

Exclusion Criteria

I have been diagnosed with osteoporosis.
Smoking
I have a history of chronic infections.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Participants undergo a 4-week period of baseline monitoring before treatment

4 weeks

Treatment

Participants receive Acthar gel with initial dosing of 40 U every 72 hours for 4 weeks, followed by 80 U for up to 16 weeks

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Acthar gel
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Acthar gelExperimental Treatment1 Intervention

Acthar gel is already approved in United States, European Union, Japan for the following indications:

🇺🇸
Approved in United States as Acthar Gel for:
🇪🇺
Approved in European Union as Synthetic ACTH (e.g., tetracosactide) for:
🇯🇵
Approved in Japan as Synthetic ACTH (e.g., tetracosactide) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Mallinckrodt

Industry Sponsor

Trials
202
Recruited
15,700+

Mario Saltarelli

Mallinckrodt

Chief Medical Officer

MD

Siggi Olafsson profile image

Siggi Olafsson

Mallinckrodt

Chief Executive Officer

PhD in Pharmacy

Published Research Related to This Trial

Acthar Gel significantly reduces corticosteroid use in patients with sarcoidosis compared to other treatments, with a notable decrease in both overall and extended corticosteroid use after treatment.
Patients who adhered better to Acthar Gel treatment experienced even greater reductions in corticosteroid exposure, highlighting the importance of adherence for maximizing treatment benefits.
Corticosteroid Use and Adherence in Patients Treated with Acthar Gel for Advanced Sarcoidosis.Hayes, K., Niewoehner, J., Rice, JB., et al.[2023]
In a multicenter, randomized, placebo-controlled trial involving 55 subjects, repository corticotropin injection (RCI) showed greater improvement in a novel sarcoidosis treatment score (STS) compared to placebo, suggesting its potential efficacy in treating pulmonary sarcoidosis.
RCI was found to be safe and well tolerated, with more patients in the RCI group able to discontinue glucocorticoids compared to those receiving placebo, indicating a promising alternative therapy for patients with pulmonary sarcoidosis.
Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis.Mirsaeidi, M., Baughman, RP., Sahoo, D., et al.[2023]
In a retrospective review of 6 patients with ocular sarcoidosis treated with subcutaneous repository corticotropin gel (RCI), most did not achieve sufficient control of ocular inflammation and had to continue using corticosteroids.
Two-thirds of the patients experienced significant side effects, including hyperpigmentation, alopecia, and severe hypertension, leading to the discontinuation of RCI therapy in 5 out of 6 patients.
Outcomes of Repository Corticotropin Gel for Ocular Sarcoidosis.Oh, DJ., Singh, A., Kanu, LN., et al.[2022]

Citations

Corticosteroid Use and Adherence in Patients Treated with Acthar Gel for Advanced Sarcoidosis. [2023]
Results From a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Repository Corticotropin Injection for the Treatment of Pulmonary Sarcoidosis. [2023]
Outcomes of Repository Corticotropin Gel for Ocular Sarcoidosis. [2022]
Response to Acthar Gel in sarcoidosis uveitis: A prospective open label study. [2023]
Acthar® Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence. [2023]
Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records. [2020]
Cost-Effectiveness of Acthar Gel versus Standard of Care for the Treatment of Advanced Symptomatic Sarcoidosis. [2023]
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