Use of CXCL9 as a Biomarker of Acthar Efficacy

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Sarcoidosis

Treatments: Drug: Acthar gel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02523092

15-17300

Details and patient eligibility

About

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).

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Acthar gel

Experimental group

Description:

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.

Treatment:

Drug: Acthar gel