Use of CXCL9 as a Biomarker of Acthar Efficacy

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02523092

Collaborator

Mallinckrodt (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Sarcoidosis	Drug: Acthar gel	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of CXCL9 as a Biomarker of Acthar Efficacy

Anticipated Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Acthar gel Acthar gel given IM or SQ as per package insert Other Names: Acthar

Arm

Intervention/Treatment

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.

Drug: Acthar gel

Acthar gel given IM or SQ as per package insert

Other Names:

Acthar

Outcome Measures

Primary Outcome Measures

Decrease in blood CXCL9 levels by 50% [within 6 months]

Secondary Outcome Measures

Improvement in FVC by 5% of predicted [within 6 months]
Improvement in dyspnea score [within 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Biopsy-proven diagnosis of sarcoidosis with demonstrated pulmonary involvement
Refractoriness to or intolerance of immunosuppressive agents like prednisone or methotrexate