Use of CXCL9 as a Biomarker of Acthar Efficacy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/4/2018 |
| Start Date: | June 2019 |
| End Date: | December 2026 |
| Contact: | Laura Koth, MD |
| Email: | laura.koth@ucsf.edu |
| Phone: | 415-514-4369 |
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).
sarcoidosis will lead to improved symptoms and lung function and correlate with decreased
levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).
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.
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.
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Laura Koth, MD
Phone: 415-514-4369
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