Use of CXCL9 as a Biomarker of Acthar Efficacy

Sarcoidosis Clinical Trial

— Acthar  

Official title:

Use of CXCL9 as a Biomarker of Acthar Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523092
• Other study ID #: 15-17300
• Status: Recruiting
• Phase: Phase 4
• Start date: November 3, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: Laura Koth, MD
• Phone: (415) 514-4369
• Email: Laura.Koth[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcoidosis

Intervention

Drug:
• Acthar gel
Acthar gel given IM or SQ as per package insert

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Mallinckrodt

Country where clinical trial is conducted

United States, 

References & Publications (1)

Su R, Li MM, Bhakta NR, Solberg OD, Darnell EP, Ramstein J, Garudadri S, Ho M, Woodruff PG, Koth LL. Longitudinal analysis of sarcoidosis blood transcriptomic signatures and disease outcomes. Eur Respir J. 2014 Oct;44(4):985-93. doi: 10.1183/09031936.00039714. Epub 2014 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in blood CXCL9 levels by 50%		within 6 months
Secondary	Improvement in FVC by 5% of predicted		within 6 months
Secondary	Improvement in dyspnea score		within 6 months

External Links

•   Homepage for the Sarcoidosis Research Program at the University of California, San Francisco