Acthar Gel for Sarcoidosis
(Acthar Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Monitoring
Participants undergo a 4-week period of baseline monitoring before treatment
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acthar gel
Acthar gel is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy