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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

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Who is running the clinical trial?

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

16,214 Total Patients Enrolled

6 Trials studying Sarcoidosis

105 Patients Enrolled for Sarcoidosis

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,541 Total Patients Enrolled

2 Trials studying Sarcoidosis

245 Patients Enrolled for Sarcoidosis

Laura Koth, MDPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

175 Total Patients Enrolled

Media Library

Acthar gel (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02523092 — Phase 4

Sarcoidosis Research Study Groups: Acthar gel

Sarcoidosis Clinical Trial 2023: Acthar gel Highlights & Side Effects. Trial Name: NCT02523092 — Phase 4

Acthar gel (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02523092 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are regularly treated with Acthar gel?

"Acthar gel has been proven efficacious in treating acute coryza, rheumatoid arthritis, juvenile-onset conditions, and optic neuritis."

Answered by AI

Am I eligible for participation in this clinical research?

"Acceptance to this sarcoidosis trial is restricted to those between 18 and 65 years of age. There are a total of 14 spots available for applicants."

Answered by AI

Are there still opportunities to join this research endeavor?

"As reported on clinicaltrials.gov, this medical trial is no longer actively searching for participants. Initially listed in October of 2020 and most recently updated in March of the same year, although not recruiting at present, 41 other studies are currently enrolling patients."

Answered by AI

Where have other experiments involving Acthar gel been conducted?

"Currently, there are 9 clinical trials related to Acthar gel. 2 of those experiments have advanced to the third phase of testing. Most studies for this medication occur in Minneapolis, Minnesota but other 104 sites across America are also conducting research on it."

Answered by AI

Are there any age limitations regarding enrollment in this experiment?

"This research seeks out participants who are of adult age (18+) and have yet to reach the retirement years (65-)."

Answered by AI

How deleterious are the effects of Acthar gel for those participating in treatment?

"There is existing evidence that Acthar gel has been approved, resulting in this treatment receiving a score of 3 on the safety scale."

Answered by AI

How many individuals will be recruited for this clinical experiment?

"This clinical trial is no longer recruiting. It was first posted October 1st 2020 and the last update occured on March 23rd of this year. If you are still searching for studies, there are 32 trials actively looking for participants with sarcoidosis and 9 Acthar gel related experiments in need of volunteers."

Answered by AI

Recent research and studies

European Respiratory JournalJournal

Longitudinal Analysis of Sarcoidosis Blood Transcriptomic Signatures and Disease Outcomes

Su, Robert, Michael M. Li, Nirav R. Bhakta, Owen D. Solberg, Eli P.B. Darnell, Joris Ramstein, Suresh Garudadri, Melissa Ho, Prescott G. Woodruff, and Laura L. Koth. 2014. “Longitudinal Analysis of Sarcoidosis Blood Transcriptomic Signatures and Disease Outcomes”. European Respiratory Journal. European Respiratory Society (ERS). doi:10.1183/09031936.00039714.

clinicaltrials.govStudy

Use of CXCL9 as a Biomarker of Acthar Efficacy

2022. "Use of CXCL9 as a Biomarker of Acthar Efficacy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02523092.

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