Use of CXCL9 as a Biomarker of Acthar Efficacy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Use of CXCL9 as a Biomarker of Acthar Efficacy

Conditions
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Sarcoidosis

Intervention / Treatment
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* Drug: Acthar gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acthar gel<br>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. | Drug: Acthar gel<br>* Acthar gel given IM or SQ as per package insert<br>* Other names: Acthar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in blood CXCL9 levels by 50% |  | within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in FVC by 5% of predicted |  | within 6 months | 
| Improvement in dyspnea score |  | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoidosis, Acthar, CXCL9, chemokine ligand 9