Use of CXCL9 as a Biomarker of Acthar Efficacy (Acthar)
Primary Purpose
Sarcoidosis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acthar gel
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring sarcoidosis, Acthar, CXCL9, chemokine ligand 9
Eligibility Criteria
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
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acthar gel
Arm 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.
Outcomes
Primary Outcome Measures
Decrease in blood CXCL9 levels by 50%
Secondary Outcome Measures
Improvement in FVC by 5% of predicted
Improvement in dyspnea score
Full Information
NCT ID
NCT02523092
First Posted
August 10, 2015
Last Updated
May 10, 2023
Sponsor
University of California, San Francisco
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT02523092
Brief Title
Use of CXCL9 as a Biomarker of Acthar Efficacy
Acronym
Acthar
Official Title
Use of CXCL9 as a Biomarker of Acthar Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Mallinckrodt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
sarcoidosis, Acthar, CXCL9, chemokine ligand 9
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acthar gel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Acthar gel
Other Intervention Name(s)
Acthar
Intervention Description
Acthar gel given IM or SQ as per package insert
Primary Outcome Measure Information:
Title
Decrease in blood CXCL9 levels by 50%
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
Improvement in FVC by 5% of predicted
Time Frame
within 6 months
Title
Improvement in dyspnea score
Time Frame
within 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Koth, MD
Phone
(415) 514-4369
Email
Laura.Koth@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Koth, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Koth, MD
Phone
415-514-4369
Email
laura.koth@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Laura Koth, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25142485
Citation
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.
Results Reference
background
Links:
URL
http://sarcoidosis.ucsf.edu/
Description
Homepage for the Sarcoidosis Research Program at the University of California, San Francisco
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Use of CXCL9 as a Biomarker of Acthar Efficacy
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