Use of CXCL9 as a Biomarker of Acthar Efficacy
Purpose
The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).
Condition
- Sarcoidosis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acthar gel |
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. |
|
Recruiting Locations
San Francisco, California 94143
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Francisco
Detailed Description
The investigators will test whether Acthar gel's anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.