Testing CXCL9 as a marker for Acthar's effectiveness in sarcoidosis
Use of CXCL9 as a Biomarker of Acthar Efficacy
This study is testing if a treatment called Acthar gel can help people with lung sarcoidosis feel better and breathe easier, while also checking if changes in a blood marker called CXCL9 relate to their improvement.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | methotrexate, prednisone |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT02523092 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy of Acthar gel in patients with pulmonary sarcoidosis by measuring its impact on symptoms and lung function. Researchers will monitor levels of the biomarker CXCL9 in the blood to determine if its decrease correlates with clinical improvements. The study will involve participants who have a confirmed diagnosis of sarcoidosis and have not responded to standard immunosuppressive treatments. The goal is to establish a link between the biomarker levels and patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are individuals with biopsy-proven pulmonary sarcoidosis who have not tolerated or responded to immunosuppressive medications.
Not a fit: Patients with active cancer, chronic infections, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with sarcoidosis who do not respond to conventional therapies.
How similar studies have performed: Previous studies have shown promise in using biomarkers to predict treatment outcomes in sarcoidosis, but this specific approach with Acthar is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement * Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate Exclusion Criteria: * Smoking * Cancer * Chronic infections (e.g. tuberculosis, viral, fungal, bacterial) * Inflammatory conditions * Coexisting lung disease * Congestive heart failure * Uncontrolled hypertension * Recent surgery * Active peptic ulcers * Osteoporosis
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Laura Koth, MD — University of California, San Francisco
- Study coordinator: Laura Koth, MD
- Email: Laura.Koth@ucsf.edu
- Phone: (415) 514-4369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.