Use of CXCL9 as a Biomarker of Acthar Efficacy

Phase 4

Recruiting

• Conditions: Sarcoidosis
• Interventions: Drug: Acthar gel

• Registration Number: NCT02523092
• Lead Sponsor: University of California, San Francisco

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).

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 Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-14
• Study Start: 2022-11-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acthar gel	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.

Primary Outcome Measures

Name	Time	Method
Decrease in blood CXCL9 levels by 50%	within 6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in FVC by 5% of predicted	within 6 months
Improvement in dyspnea score	within 6 months

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States