NCT02523092

Use of CXCL9 as a Biomarker of Acthar Efficacy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	Acthar gel	Acthar gel given IM or SQ as per package insert

Timeline

• Start date: 2022-11-03
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2015-08-14
• Last updated: 2023-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study